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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Post coronary angioplasty patients, |
|
Intervention / Comparator Agent
|
|
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 angioplastyâ€: 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. |