HIGHLIGHTS OF OUR SITE

• Highly qualified and experienced Principal Investigators.
• A large primary patient database drawn from our private practice.
• 48 hour turn around on all regulatory documents, budgets, research agreements.
• Study approvals usually within 2 weeks.
• Eight cardiologists who refer eligible patients for our studies.

We also provide transportation services for patients to assure ease of compliance. Our staff is multilingual, which helps in better communication with patients.

Affiliated medical facilities and hospitals
1. SAL Hospital & Medical Institute
2. Apollo Hospital
3. Krishna Heart Institute
4. Sheth V. S. General Hospital

Following services are provided at the Hospitals

• Entire gamut of Coronary Interventions.
• Pediatric Cardiac Interventions.
• Cardiac Electrophysiology - EP Study, RF Ablation, Pacemaker Implantation, AICD Implantation, Cardiac Resynchronisation etc.
• Cardiothoracic Surgery including on pump and off pump CABG, Valve Surgery, Pediatric Cardiac Surgery etc.

This site is unique because of its expertise and specialization in Cardiology. A renowed team of 18 Cardiologists, Electro physiologist & Cardiothoracic surgeons are participating & spearheading new devices and surgical techniques with outstanding results. With the team of experts, we offer comprehensive services to conduct phase I-III device trials and post-marketing surveilence.

Resource Persons:
Dr. Keyur Parikh

• Highly acclaimed interventional cardiologist leads a team of cardiologists performing 3500 coronary interventions
  every year.  He is  a great combination of high intelligence and innovative mind with very keen interest in clinical research.
• He has participated in several international clinical studies as the Principal Investigator.
• He has successfully executed 1st in human implantation of coronary devices. (In CS, Stent like device for retroperfusion in patients with CAD & implantable ultrasonic device for PA pressure measurement in patients  with heart failure).
• He has high acumen of knowledge & his skills in coronary device projects are unmatched.

Dr. Anil Jain
He is one of the leading cardiothoracic surgeons in India. He leads a team of dynamic cardiothoracic surgeons, cardiac anaesthesiologists & intensivists.  The team performs 1200 bypass surgeries in addition to valvular surgeries, pediatric cardiac surgeries per year. He is very enthusiastic about clinical research and has participated in several studies in capacity of PI & sub investigator.

The Heart Care Clinic is an investigative site involved in Phase I-IV cardiology drug & device trials. Our dedicated team is well trained in conducting out-patient studies at The Heart Care Clinic & in-patient studies at our affiliated local hospitals, stringently adhering to FDA regulations & ICH-GCP guidelines.

Dr Keyur Parikh, the Chairman of The Heart Care Clinic has participated in several clinical studies and has been a Principal Investigator for many cardiovascular studies. Dr Milan Chag, the Vice Chairman  also has participated as PI in many cardiovascular studies. Dr Anil Jain is the Managing Director and chief cardiac surgeon and also has extensive experience in cardiovascular studies.

Other cardiologists are also involved in research either as PI or Sub-investigators. The core team is rich in skills & experience. It has successfully completed numerous international clinical research projects, which have resulted into publications in reputed international journals. This is the largest group practice physician network in India offering comprehensive cardiac care including pediatric cardiology & electrophysiology.  

The Heart Care Clinic has an extensive database of over 30,000 covering the whole spectrum of cardiovascular disease. We also have a comprehensive database of the catheterization procedures including PCI, PTCAs, Paediatric Intervention, RP studies, radiofrequency, ablation and various device implantations. Patient records are computerized, allowing search for a specific patient population and enabling streamlining the screening and patient tracking process.

FACILITY DESCRIPTION

The Heart Care Clinic serves as an investigative site. It is located at a very convenient location along the SG Highway, approximately 20 kms from the international & domestic airports. Major hotels and restaurants are located near  The Heart Care Clinic.

The office of The Heart Care Clinic is specially designed and equipped to conduct OPD studies on site. This site is situated near SAL Hospital & Medical Institute, a 300 bed multi-speciality hospital, with which it enjoys a close working affiliation.
Following services are provided from the Heart Care Clinic

• ECG
• Echocardiography
• Treadmill test
• Cardiac stress test
• Holter monitoring
• Pacemaker programming
• Secure pharmacy and cold storage facility for drugs
• Laboratory with centrifuge
• Examination rooms
• Treatment room with bed and injection / infusion facility
• Data storage and medical records storage facility

Dr. Ajay Naik (MD, DM, DNB, FACC)
He is a specialist in Electrophysiology and Management of  Cardiac Arrhythmia management & heart failure . Trained at  Cedars Sinai Medical Centre, L.A., USA for a fellowship in Electrophysiology (EP), he has performed innumerable EP procedures and device implantations.

He is one of the foremost implanters of various devices such as AICD, Biventricular pacemakers (CRT) & other pacemakers in India. He is also trained and experienced in non-contact Electrophysiology mapping systems including Carto-Biosense, ESI & RPM and is known for technical skills as well as comprehensive management of complex clinical problems. He has large number of publications in reputed national & international journals to his credit . He has wide exposure to basic and clinical research. He  has been trained in animal experiments of Cardiac device implants & Cardiac EP research and has coordinated several multi center  international  clinical trials.

CLINICAL RESEARCH EXPERIENCE

• Experience : Phase I-IV studies, in-patient and out-patient
• Cardiology Therapeutics : Dealing with Angina, Acute Myocardial Infarction, Arrhythmia, Pulmonary Hypertension, Acute, Coronary Syndrome, Heart failure, Pediatric Cardiology 
• Cardiac Surgery : Various modalities of surgery including heart failure surgery
• Investigative products handled : Drugs & devices
• Results : One of the highest enrolling sites in the country for ongoing & completed trials.
• Sponsors/CROs worked with:
  „        Aventis
  „        Kowa Research
  „        Neovasc Medical
  „        NIH
  „        Pharmanet             
  „        Quintiles
  „        Remon Medical technology
  „        Sankyo Pharma Development
  „        Sanofi-Synthelabo
  „        United therapeutics
  „        Asian Clinical Trials Pvt. Ltd.

PATIENT DEMOGRAPHICS

The Heart Care Clinic is located in the heavily populated city of Ahmedabad, which serves as a tertiary care city for total a population of over 30 Million, which includes states of Gujarat, Rajasthan and Madhya Pradesh.

We have a huge patient database. We have an established network of physicians of Gujarat, Rajasthan and M.P.

For out-patient trials, conducted at The Heart Care Clinic an Institutional Ethics Committee, meets as necessary, to facilitate meeting the sponsor’s requirements. Approximate turn around time is 2 - 4  weeks from receipt of all pertinent study materials. The approval can be expedited in situations where it is necessary.

For in-house trials, we use the IRB of respective hospitals. The IRB meets as necessary and turn around time is 2 - 4 weeks from receipt of all pertinent study materials.