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CTRI Number  CTRI/2017/12/010728 [Registered on: 01/12/2017] Trial Registered Retrospectively
Last Modified On: 24/11/2017
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   To assess the factors influencing major adverse cardiac events after undergoing a non-surgical procedure used for the treatment of coronary artery disease. 
Scientific Title of Study   Assessment of factors associated with major adverse cardiac events after undergoing percutaneous transluminal coronary angioplasty. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prasad Shetty  
Designation  Junior Research Fellow, Department of Cardiology  
Affiliation  Kasturba Medical College  
Address  Department of Cardiology, Kasturba Medical College, Madhava Nagar, Manipal University, Near Tiger Circle, Manipal, Udupi, Karnataka 576104, India

Udupi
KARNATAKA
576104
India 
Phone  9964026792  
Fax    
Email  dr.prasadnshetty@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tom Devasia  
Designation  Head of the Department of Cardiology  
Affiliation  Kasturba Medical College  
Address  Department of Cardiology, Kasturba Medical College, Madhava Nagar, Manipal University, Near Tiger Circle, Manipal, Udupi, Karnataka 576104, India

Udupi
KARNATAKA
576104
India 
Phone  9848158508  
Fax    
Email  tomdevasia@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prasad Shetty  
Designation  Junior Research Fellow, Department of Cardiology  
Affiliation  Kasturba Medical College  
Address  Department of Cardiology, Kasturba Medical College, Madhava Nagar, Manipal University, Near Tiger Circle, Manipal, Udupi, Karnataka 576104, India

Udupi
KARNATAKA
576104
India 
Phone  9064026792  
Fax    
Email  dr.prasadnshetty@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College, Madhava Nagar, Manipal University, Near Tiger Circle, Manipal, Udupi, Karnataka 576104, India  
 
Primary Sponsor  
Name  Kasturba Medical College 
Address  Madhava Nagar, Manipal University, Near Tiger Circle, Manipal, Udupi, Karnataka 576104, India  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prasad Shetty   Kasturba Medical College   Department of Cardiology, Kasturba Medical College, Madhava Nagar, Manipal University, Near Tiger Circle, Manipal, Udupi, Karnataka 576104, India
Udupi
KARNATAKA 
9964026792

dr.prasadnshetty@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Hospital, Manipal   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Post coronary angioplasty patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. South Indian Patients of both gender aged between 18-65 years who undergo coronary angioplasty.
2. Patients who agreed and consented to participate in the study.
 
 
ExclusionCriteria 
Details  1. Patients with moderate or severe LV dysfunction, EF less than 40 percent.
2. Cardiogenic shock on presentation/ during hospitalization.
3. Patients with Chronic Kidney Disease.
4. Patients with proven Psychiatric illness on medications.
5. Patients whose viral markers positive.
6. Pregnant women
7. Terminal malignancy patients with life expectancy less than one year.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Composite of Major Adverse Cardiac Events  From the day of discharge to 24 months of follow up 
 
Secondary Outcome  
Outcome  TimePoints 
Life style modification and Health related Quality of life in Post coronary angioplasty patients  From the day of discharge to 24 months of follow up. 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/06/2015 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   1.“Association between weight loss and Anxiety, depression one month after percutaneous transluminal coronary angioplasty”: A need for pre-discharged counselling. Prasad Narayana Shetty, Devasia Tom Yeshwanth Rao Karkal, Ajit Singh, Hashir Kareem.Asian journal of pharmaceutical science and clinical research Vol 10, issue 8,2017 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Coronary artery disease (CAD) is the leading cause of the death in the western world presently. The complicated lifestyle choice, unhealthy diet pattern and poor physical activity made its way acutely to India. Lately, non-communicable CAD has substituted tuberculosis, which was the top killer in 199. Coronary heart disease is the most common type of heart disease, it is estimated that every year 2.4 million Indians die due to the coronary heart disease, out of this 30% from the urban and 15 percent from the rural population.

Percutaneous transluminal coronary angioplasty (PTCA) otherwise known as coronary revascularization is the safe and effective treatment of choice in acute coronary syndrome (ACS). Which augments better symptom relief and enhanced quality of life of the patients, thus reduced the mortality rate. The term major adverse cardiac events (MACE) is a commonly used endpoint for cardiovascular research. By definition, MACE is a composite of clinical events and usually includes endpoints reflecting safety and effectiveness.

 ACC/AHA defines MACE as Cardiac death, nonfatal reinfarction, clinically driven target lesion revascularization (TLR) or target vessel revascularization (TVR), stroke and all-cause mortality, which requires unplanned hospitalization or emergency room visit. The incidence of MACE is 30 percent after coronary angioplasty.

Lifestyle modification is indicated for all patients with coronary artery syndrome, irrespective of drug therapy. There is strong evidence that regular physical activity has an independent cardio-protective effect. Un-healthy diet, sedentary life, tobacco abuse, high blood pressure, high blood sugar and blood cholesterol level are identified cardiac risk factors, it is mandatory to avoid those after coronary revascularization with regular follow-up and proper medication for healthy and better quality of life.

An occurrence of MACE in post-angioplasty patients is identified in many international studies, but through this study, we will assess the MACE in South Indian population after the procedure on different follow-ups (1, 6, 12 and 24 months). This study will reveal the important factors which influence the occurrence of the MACE after PTCA.

The aim of current study is to assess the major adverse cardiac events (MACE) and to identify the various factors influencing MACE.

Objectives of the study is 

1. To assess the occurrence rate of MACE among a cohort of post-angioplasty subjects 

2. To evaluate the various influencing factors including anthropometric, social, economic and demographic factors

3. To assess the adherence to lifestyle modification and Health-related quality of life in post-angioplasty patients  

Source of data collection and study material

Patients will be recruited for this study if they have undergone coronary angioplasty. These patients will be chosen after consideration of inclusion and exclusion criteria. Informed consent will be taken from subjects. Collection of data including demographic history, present medication, and different lab test reports along with ECG, Echo, coronary angiogram and angioplasty. As the study will be carried out prospectively, material and data will be collected during hospitalization and on follow up. Results will be documented in a customized form or form designed by an organization, containing complete details of patients medications and investigations. On discharge, patient will be asked to come for follow up on 1, 6, 12, 18 and 24 months with proper instruction and standard counseling about the risk factors, life style modification and awareness about need for long term therapy (Drug compliance) for prevention of recurrent events and complications. On each follow up we will document the blood pressure and blood test reports of the patients. There will be assessment of MACE and angina by history and tests like ECG, Echo, TMT and repeat CAG, if needed .We will also assess the base line characteristics including co-morbidities, and anthropometry measurements. We will also note any change of medications done on follow up, as well as enquire about quality of life according to WHO Quality of Life questionnaire. After completion of patient’s data collection, entry will be done and data will be analyzed to get results.  After the completion of study, documentation and reporting will be done according to protocol. 
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