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SAL Hospital and Medical Institute
Apollo Hospital
Krishna Heart Institute
   
 

Research Projects undertaken by Care Cardiovascular Consultants as an Investigator

Investigational Product

Indication

Study Phase

Status

Pharmacological Agent

1. EXTRACT TIMI-25 (LMWH)

Acute Coronary Syndrome

III

Study completed, 100% Follow up

1. OASIS 5 (LMWH)

Acute Coronary Syndrome

III

Study completed, 100% Follow up. One of the highest enrollments in the country.

2. OASIS 6 (LMWH)

Acute Myocardial Infarction

III

Enrollment completed.100% Follow up of enrolled patients.

3. Angiotensin Receptor Blocker

Pediatric Hypertension

III

Currently enrolling.

4. Prostacyclin Analogue

Pulmonary Hypertension

III

Officially closed

5. Newer Generation Statin

Hyperlipidemia

III

Currently enrolling.

6. Aspiration Device

Acute Myocardial Infarction

III/IV

Currently enrolling.

7.Anticoagulant Therapy

Non-valvular Atrial Fibrillation

III

Currently enrolling

 

Surgery

Comparison of CABG and optimum medical therapy

Coronary Artery Disease

 

Currently enrolling.


Device

Neovasc

Coronary Sinus stent like device for retro perfusion in patients with Coronary Artery Disease.

Status: 1st in human study, 10 Patients have Successfully completed study period with 100% follow-ups. (Out of 15 patients worldwide)

Papirus

Implantable Ultrasonic device for PA pressure easurement in patients with Heart failure

Status: 1st in human study, All the 10 enrolled patients have completed study period.


Registry

Ruby

Registry for Percu Serge™ Gaurdwire system.

Status: 100% followup.

E-Cypher

Registry for CYPHER™ Stent.

Status: Enrolled 220 patients, 100% followup.

E-5

Drug Eluting stent.

Status: Enrollment Completed.

Panorama

CRM Implantable Cardiac Device Long term observation Registry

Status: Currently Enrolling.

DIRECT

Digital pacemaker Registry

Status: Enrollment Completed.


NATIONAL CLINICAL TRIALS:
1. Tirofiban Registry

Protocol Title: An open multicentric study to assess the efficacy and safety of Tirofiban hydrochloride in patients with acute coronary syndrome (unstable angina or non Q- wave Myocardial Infarction

Status: Completed 2003

PROJECTS UNDERTAKEN BY VIBGYOR FOR INDEPENDENT INVESTIGATORS.

  1. Effect of Folate treatment on Homocystenemia in cardiac patients: A prospective study.
  2. Reversal of Slow or no reflow during Percutaneous Transluminal Coronary Angioplasty during intracoronary boluses of Adenosine and Sodium Nitroprusside in combination.
  3. Pharmacoepidemiology and Risk factors of Hypertension in western Gujarat.
  4. Effect of statins and their combination with fenofibrate in patients undergoing percutaneous transluminal coronary angioplasty.
  5. Effect of Niacin treatment on hyperlipoproteinemia in coronary artery disease patients.
  6. Effect of combinations of various intracoronary drugs in no-reflow patients undergoing percutaneous coronary intervention.
  7. Comparison of drug eluting stent with conventional S7 stent.
  8. The use of distal protection device (dpd) during angioplasty and to compare the acute long-term events of intracoronary injections of drugs in no-reflow as compared to distal protection device.
  9. Assessment of risk factors for coronary artery disease.
  10. High prevalence of renal artery stenosis in hypertensive patients with triple vessel coronary artery disease: recommendation for simultaneous renal
  11. Arteriogram for earlier intervention.
  12. Effect of pioglitazone and its combination with statins in CAD patients with hyperinsulinemia.
  13. Safety and Efficacy of High Dose Intracoronary bolus of tirofiban in patients with AMI undergoing Primary / Rescue coronary angioplasty.
  14. Short term and Long term effect of Metoprolol XL on PAP in patients with CHF using first in human implantable device responding to ultransonic signal.
  15. Comparison of Short Term and Long term Effect of Metoprolol XL versus Carvedilol on Pulmonary artery Pressure in patients with chronic Heart Failure using first in human implantable device responding to ultrasonic signal.
  16. First in human CT angiography images of "Pulmonary artery Stenting with a transducer device" in patients with heart failure.
  17. Effects of Cardiac Rehabilitiation on PA pressure in patients with Chronic Heart Failure using first in human implantable device responding to ultrasonic signal.
  18. How to treat Heart Failure? Is there any difference after ambulatory PA pressure monitoring.
  19. Diurnal variation in PA pressure measured using First in Human implantable device responding to ultrasonic signals .
  20. Association of BNP and PA pressure monitored through first in human implantable device in patients with HF .
  21. Acute effects on Pulmonary artery pressure, on rest and after exercise in patients in patients with heart failure (EF<35%) using first in human implantable device for PAP responsing to ultrasonic signals.
  22. Comparison of Chronical HF device (Medtronic) versus Remon CHF system (Remon) for ambulatory PAP measurement in patients with heart failure .
  23. First in human pilot study of safety and efficacy of Neovasc Reducer Implant in the treatment of ischemic heart disease by controlled narrowing of the coronary sinus, in patients with No-Options.
  24. Evaluation of Coronary arterial system and collaterals subsequent to first in human Neovasc Reducer TM Implantation in Coronary Sinus in “No Options” patients using 40 Slice Multi-detector Computed Tomography .
  25. Non invasive Visualization of first in human Neovasc Reducer TM Implant in Coronary Sinus using 40 Slice Multi-detector Computed Tomography.
  26. Effect of Coronary Sinus Retroperfusion Stent (Neovasc Reducer®) on angiogenic , inflammatory and genetic markers .


Abstracts Presented in ACC '2006
1. Parikh KH, Shah HD, et al. First in Human Implanted Device in Pulmonary Artery Using Acoustic Telemetry Based On Non-Invasive Ultrasound Activation and Communication American College of Cardiology Conference, March 2006

2. Parikh KH, Shah HD, et al. Correlation Between Multislice CT Angiography, 2D-Echocardiography and Invasive Angiography For Determination Of Pulmonary Artery Size. American College of Cardiology Conference, March 2006

3. Parikh KH, Shah HD, et al. CT Angiography Visualization Of First-in-man Coronary Sinus Reducer Tm Stent In Patients With Refractory Angina. American College of Cardiology Conference, March 2006

4. Parikh KH, Shah HD, et al. Effect Of Metoprolol XL On Exercise Capacity And Subsequent Variation In Pulmonary Artery Pressure In Heart Failure Patients Using First-in-man Implantable Device Responding To Ultrasonic Signals . American College of Cardiology Conference, March 2006

5. Parikh KH, Shah HD, et al. Direct Comparison Of Conventional Coronary Sinus Angiography And CT Angiography For Visualization And Sizing Of Coronary Sinus . American College of Cardiology Conference, March 2006

6. Parikh KH, Shah HD, et al. Non invasive Measurement of Variation In Pulmonary Artery Pressure Following Exercise In Heart Failure Patients Using First In Human Implantable Device Responding To Ultrasonic Signals . American College of Cardiology Conference, March 2006

7. Parikh KH, Shah HD, et al. Multislice CT Angiography Visualization Of An Innovative First-in-man Remon CHF® Implant For Measurement Of Pulmonary Artery Pressure In Heart Failure Patients. American College of Cardiology Conference, March 2006

8. Parikh KH, Shah HD, et al. Effect Of Metoprolol XL on Pulmonary Artery Pressure In Patients With Heart Failure Measured Using First In Human Implantable Device Responding To Ultrasonic Signal . American College of Cardiology Conference, March 2006 (Submitted)

9. Parikh KH, Shah HD, et al. First in Human Non-invasive Monitoring Of Pulmonary Artery Pressure From An Implanted Device Using Acoustic Telemetry . American College of Cardiology Conference, March 2006 (Submitted)

10. Parikh KH, Shah HD, et al. Effect Of Metoprolol XL On Diurnal Variation In Pulmonary Artery Pressure Measured Non-invasively Using First In Human Implant Responding To Ultrasonic Signals . American College of Cardiology Conference, March 2006 (Submitted)

11. Parikh KH, Shah HD, et al. Measurement of Diurnal Variation In Pulmonary Artery Systolic and Diastolic Pressure in Heart Failure Patients Using First-In-Human Implantable Device Responding To Ultrasonic Signals . American College of Cardiology Conference, March 2006 (Submitted)

 

Papirus

Implantable Ultrasonic device for PA pressure measurement in patients with Heart failure

Status: 1st in human study, All the 10 enrolled patients have completed study period of 6 months.

Registry

Ruby

Registry for PercuSurge™ Gaurdwire system.

Status: 100% followup.

E-Cypher

Registry for CYPHER™ Stent.

Status: Enrolled 220 patients, 100% followup.

E-5

Drug Eluting stent.

Status: Currently enrolling

Panorama

CRM Implantable Cardiac Device Long Term Observational Study

Status: Currently Enrolling.

DIRECT

Digital pacemaker Registry

Status: Currently enrolling


NATIONAL CLINICAL TRIALS:
1. Tirofiban Registry

Protocol Title: An open multicentric study to assess the efficacy and safety of Tirofiban hydrochloride in patients with acute coronary syndrome (unstable angina or non Q- wave Myocardial Infarction

Status: Completed 2003

PROJECTS UNDERTAKEN BY CARE CARDIOVASCULAR CONSULTANTS

  1. Effect of Folate treatment on Homocystenemia in cardiac patients: A prospective study.
  2. Reversal of Slow or no reflow during Percutaneous Transluminal Coronary Angioplasty during intracoronary boluses of Adenosine and Sodium Nitroprusside in combination.
  3. Pharmacoepidemiology and Risk factors of Hypertension in western Gujarat.
  4. Effect of statins and their combination with fenofibrate in patients undergoing percutaneous transluminal coronary angioplasty.
  5. Effect of Niacin treatment on hyperlipoproteinemia in coronary artery disease patients.
  6. Effect of combinations of various intracoronary drugs in no-reflow patients undergoing percutaneous coronary intervention.
  7. Comparison of drug eluting stent with conventional S7 stent.
  8. The use of distal protection device (dpd) during angioplasty and to compare the acute long-term events of intracoronary injections of drugs in no-reflow as compared to distal protection device.
  9. Assessment of risk factors for coronary artery disease.
  10. High prevalence of renal artery stenosis in hypertensive patients with triple vessel coronary artery disease: recommendation for simultaneous renal
  11. Arteriogram for earlier intervention.
  12. Effect of pioglitazone and its combination with statins in CAD patients with hyperinsulinemia.
  13. Safety and Efficacy of High Dose Intracoronary bolus of tirofiban in patients with AMI undergoing Primary / Rescue coronary angioplasty.
  14. Short term and Long term effect of Metoprolol XL on PAP in patients with CHF using first in human implantable device responding to ultransonic signal.
  15. Comparison of Short Term and Long term Effect of Metoprolol XL versus Carvedilol on Pulmonary artery Pressure in patients with chronic Heart Failure using first in human implantable device responding to ultrasonic signal.
  16. First in human CT angiography images of "Pulmonary artery Stenting with a transducer device" in patients with heart failure.
  17. Effects of Cardiac Rehabilitiation on PA pressure in patients with Chronic Heart Failure using first in human implantable device responding to ultrasonic signal.
  18. How to treat Heart Failure? Is there any difference after ambulatory PA pressure monitoring.
  19. Diurnal variation in PA pressure measured using First in Human implantable device responding to ultrasonic signals.
  20. Association of BNP and PA pressure monitored through first in human implantable device in patients with HF.
  21. Acute effects on Pulmonary artery pressure, on rest and after exercise in patients in patients with heart failure (EF<35%) using first in human implantable device for PAP responsing to ultrasonic signals.
  22. Comparison of Chronical HF device (Medtronic) versus Remon CHF system (Remon) for ambulatory PAP measurement in patients with heart failure.
  23. First in human pilot study of safety and efficacy of Neovasc Reducer Implant in the treatment of ischemic heart disease by controlled narrowing of the coronary sinus, in patients with No-Options.
  24. Evaluation of Coronary arterial system and collaterals subsequent to first in human Neovasc Reducer TM Implantation in Coronary Sinus in “No Options” patients using 40 Slice Multi-detector Computed Tomography .
  25. Non invasive Visualization of first in human Neovasc Reducer TM Implant in Coronary Sinus using 40 Slice Multi-detector Computed Tomography.
  26. Effect of Coronary Sinus Retroperfusion Stent (Neovasc Reducer®) on angiogenic, inflammatory and genetic markers.

 

Abstracts:

  1. Parikh KH, Chag MC, Shah UG, Baxi HA, Chandarana AH, Naik AM, Shah HD, Goyal RK. Beneficial Effects Of Distal Protection Device In Reducing The Use Of Intracoronary Vasodilators And Glycoprotein IIb/IIIa Receptor Antagonists During Percutaneous Coronary Interventions. Poster Presentation at Annual Conference of Society of Cardiovascular Angiography and Interventions (SCAI), San Diego, May 2004

  2. Abstract published in Catheter and Cardiovasc Interven 2004; 62: pg 90.
  1. Parikh KH, Shah HD,  Chag MC, Shah UG, Baxi HA, Chandarana AH, Naik AM, Goyal RK. Revascularization In Acute Myocardial Infarction Using Percusurge In Distal Protection (RAPID). Poster Presentation at Annual Conference of Society of Cardiovascular Angiography and Interventions (SCAI), San Diego, May 2004.
  1. Abstract published in Catheter and Cardiovasc Interven 2004; 62: pg 116.
  1. Parikh KH, Chag MC, Shah UG, Baxi HA, Chandarana AH, Naik AM, Shah HD, Goyal RK. Improvement In Mace By Sequential Administration Of Boluses Of Intracoronary Adenosine And Sodium Nitroprusside During Percutaneous Coroanry Interventions. Poster Presentation at Annual Conference of Society of Cardiovascular Angiography and Interventions (SCAI), San Diego, May 2004
  1. Abstract published in Catheter and Cardiovasc Interven 2004; 62: pg 130-131.

  2. Shah H, Iyer S, Mehta K, Parikh K, Jain A, Goyal RK. Pharmaco-epidemiology and risk factors of Hypertension in western Gujarat. Absract Published in Ind J Pharmacol 2003:35(4), pg. 277.

Abstracts Presented at ACC 2006

1. Parikh KH, Shah HD, et al. First in Human Implanted Device in Pulmonary Artery Using Acoustic Telemetry Based On Non-Invasive Ultrasound Activation and Communication American College of Cardiology Conference, March 2006 (Oral Presentation at late breaking Clinical trials session at ACC-i2 summit)


2. Parikh KH, Shah HD, et al. Correlation Between MultiSlice CT Angiography, 2D-Echocardiography and Invasive Angiography For Determination Of Pulmonary Artery Size. American College of Cardiology Conference, March 2006 (Poster Presentation)


3. Parikh KH, Shah HD, et al. Effect Of Metoprolol XL on Pulmonary Artery Pressure In Patients With Heart Failure Measured Using First In Human Implantable Device Responding To Ultrasonic Signal. American College of Cardiology Conference, March 2006 (Poster Presentation)


4. Parikh KH, Shah HD, et al. Effect Of Metoprolol XL On Diurnal Variation In Pulmonary Artery Pressure Measured Non-invasively Using First In Human Implant Responding To Ultrasonic Signals. American College of Cardiology Conference, March 2006 (Poster Presentation)


5. Shah HD, Goyal RK, Parikh KH, Intracoronary Boluses Of Adenosine And Sodium Nitroprusside Combination Reverses Slow/No Reflow During Angioplasty: A Clinical Scenario of Experimental Preconditioning. Oral and Poster presentation at the Young Investigator’s Awards competition

Abstracts Accepted for
ESC-World Congress of Cardiology 2006

1. First in man: measurement of diurnal variation in pulmonary artery systolic and diastolic pressure in heart failure patients using an innovative implantable device responding to ultrasonic signals.

2. First in Man: non invasive measurement of variation in Pulmonary artery pressure following exercise in heart failure patients using an innovative implantable device involving acoustic telemetry.

3. First in man: effect of Metoprolol CR/XL on exercise capacity and subsequent variation in Pulmonary Artery Pressure in Heart Failure patients using an innovative implant involving acoustic telemetry.

4. First in man non-invasive monitoring of pulmonary artery pressure from an implantable device using acoustic telemetry: a one year follow-up data.

5. First-In-Man: comparison of ImpressureTM device measuring pulmonary artery pressure non-invasively with conventional contrast echocardiography In Congestive Heart Failure.

6. First in Man study: effect of Metoprolol CR/XL on diurnal variation in pulmonary artery pressure assessed non-invasively using an innovative implantable device responding to ultrasonic signals.

  1. PRESENTATIONS in International & National Conferences:

  2. Shah HD, Parikh KH, Chag MC, Shah UG, Baxi HA, Chandarana AH, Naik AM, Patel GT, Mathan G, Shah JN, Goyal RK. Association of White Blood cell count with the occurrence of slow/no reflow in acute coronary syndrome patients undergoing PCI. Poster presentation at Joint International Conference of ISHR and IACS, Jan 2005, Gujarat, India
  1. Shah HD, Parikh KH, Chag MC, Shah UG, Baxi HA, Chandarana AH, Naik AM, Patel GT, Mathan G, Shah JN, Goyal RK. Efficacy of PercuSurge Guardwire system in acute myocardial patients undergoing Primary / rescue PCI. Oral presentation at Joint International Conference of ISHR and IACS, Jan 2005, Gujarat, India
  1. Parikh KH, Shah HD, Chag MC, Shah UG, Baxi HA, Chandarana AH, Naik AM, Goyal RK. Improvement In Mace By Sequential Administration Of Boluses Of Intracoronary Adenosine And Sodium Nitroprusside During Percutaneous Coronary Interventions. (Poster Presentation at Annual Congress) European Society of Cardiology, 2004, Munich, Germany
  1. Chag MC, Shah HD, Joshi MV, Parikh KH, Shah UG, Baxi HA, Chandarana AH, Naik AM, Shah JN, Goyal RK. Renal artery stenting is safe and effective modality of treatment on Mid Term Follow Up. Poster Presentation at 56th Annual Conference of The Cardiological Society of India (CSI) at Bangalore, December 2004
  1. Chag MC, Parikh KH, Shah UG, Baxi HA, Chandarana AH, Naik AM, Shah JN, Shah HD, Shah KJ, Goyal RK. Increased Lipoprotien(a) as a strong risk factor for Coronary artery disease and the effect of Niacin amongst Indians. Oral Presentation at 56th Annual Conference of The Cardiological Society of India (CSI) at Bangalore, December 2004

Review Articles and Research Papers:

  1. Shah HD, Iyer S, Shah K, Parikh K, Chag M, Shah U, Baxi H, Chandarana A, Naik A, Goyal RK. Effect of Statins in combination with fenofibrate in patients after percutaneous transluminal coronary angioplasty. Ind J Pharmacol 2004; 36(2): pg 113.
  1. Shah HD. Novel Agents in Osteoporosis. Ind J Pharmacol 2004;36 (1):48-9.
  1. Shah HD, Goyal RK. Novel anti-obesity agents. Ind J Pharmacol 2002; 34(5):372 - 3.
  1. Parikh KH, Shah HD, Chag MC, Shah UG, Baxi HA, Chandarana AH, Naik AM, Patel GT, Shah JN, Goyal RK. Revascularization In Acute Myocardial Infarction Using Percusurge In Distal Protection (RAPID). World Heart J (Accepted: In Press)
  1. Shah HD, Parikh KH, Chag MC, Shah UG, Baxi HA, Chandarana AH, Naik AM, Shah JN, Shah KJ, Goyal RK. Beneficial effects of addition of fenofibrate to statins in acute coronary syndrome patients undergoing Percutaneous Coronary Interventions. World Heart J (Accepted: In Press)
  1. Parikh KH, Shah HD, Chag MC, Shah UG, Baxi HA, Chandarana AH, Naik AM, Patel GT, Shah JN, Goyal RK. Revascularization In Acute Myocardial Infarction Using Percusurge In Distal Protection (RAPID). World Heart J (Accepted: In Press)
  1. Shah HD, Parikh KH, Chag MC, Shah UG, Baxi HA, Chandarana AH, Naik AM, Shah JN, Shah KJ, Goyal RK. Beneficial effects of addition of fenofibrate to statins in acute coronary syndrome patients undergoing Percutaneous Coronary Interventions. World Heart J (Accepted: In Press)
Lists of Publications:
  1. CHAPTER IN BOOKS:
  1. Shah HD, Parikh KH, Goyal RK. Recent Trends in Antiplatelet Therapy for Acute Coronary Syndromes: Glycoprotein IIb/IIIa receptor antagonists: In Pharmacotherapy of Heart Failure by S K Gupta 2005; 102:22
  1. Parikh KH, Shah HD. Stem Cell Therapy in ACS: Type, timing and promise: In The Post Graduate Medicine-2006 (In Press, Scheduled Feb 2006)
  1. Parikh KH, et al., Development of Group Practice in Cardiology, Financial planning and Research and development: CSI Book 2005
  1. Parikh KH, Shah HD, et al., Stem cell Therapy in ACS; Type, Timing and Promise: AAPI Book, 2006
  1. Mehta K N, Parikh K H, Chag MC, Shah U G, Baxi H A, Chandarana A H, Naik A M, Goyal R K, Effect of Folate Treatment on Homocysteinemia in Cardiac Patients: A Prospective Study: Indian Journal of Pharmacology;2005;Vol 37:13-17
  1. Shah K J, Iyer S S, Parikh K H, Goyal R K: Dual RAAS Blockade with ACE-I and ARB (Review) : Indian Journal of  Cardiology (In Press)

  1. Parikh KH, Chag MC, Shah UG, Baxi HA, Chandarana AH, Naik AM, Shah HD, Shah JN, Goyal RK; Beneficial effects of addition of fenofibrate to statins In acute coronary syndrome patients undergoing Percutaneous coronary interventions.: World heart Journal(accepted)

 
   
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