To assess the factors influencing major adverse cardiac events after undergoing a non-surgical procedure used for the treatment of coronary artery disease.
- Conditions
- Post coronary angioplasty patients
- Registration Number
- CTRI/2017/12/010728
- Lead Sponsor
- Kasturba Medical College
- Brief Summary
Coronary arterydisease (CAD) is the leading cause of the death in the western world presently.The complicated lifestyle choice, unhealthy diet pattern and poor physicalactivity made its way acutely to India. Lately, non-communicable CAD hassubstituted tuberculosis, which was the top killer in 199. Coronary heartdisease is the most common type of heart disease, it is estimated that everyyear 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.
Percutaneoustransluminal coronary angioplasty (PTCA) otherwise known as coronaryrevascularization is the safe and effective treatment of choice in acutecoronary syndrome (ACS). Which augments better symptom relief and enhancedquality of life of the patients, thus reduced the mortality rate. The termmajor adverse cardiac events (MACE) is a commonly used endpoint forcardiovascular research. By definition, MACE is a composite of clinical eventsand usually includes endpoints reflecting safety and effectiveness.
ACC/AHA definesMACE as Cardiac death, nonfatal reinfarction, clinically driven target lesionrevascularization (TLR) or target vessel revascularization (TVR), stroke andall-cause mortality, which requires unplanned hospitalization or emergency roomvisit. The incidence of MACE is 30 percent after coronary angioplasty.
Lifestylemodification is indicated for all patients with coronary artery syndrome,irrespective of drug therapy. There is strong evidence that regular physicalactivity has an independent cardio-protective effect. Un-healthy diet,sedentary life, tobacco abuse, high blood pressure, high blood sugar and bloodcholesterol level are identified cardiac risk factors, it is mandatory to avoidthose after coronary revascularization with regular follow-up and propermedication for healthy and better quality of life.
An occurrence of MACEin post-angioplasty patients is identified in many international studies, butthrough this study, we will assess the MACE in South Indian population afterthe procedure on different follow-ups (1, 6, 12 and 24 months). This study willreveal the important factors which influence the occurrence of the MACE afterPTCA.
The aim of currentstudy is to assess the major adverse cardiac events (MACE) and to identify thevarious factors influencing MACE.
Objectives of thestudy is
1. To assess theoccurrence rate of MACE among a cohort of post-angioplasty subjects
2. To evaluate thevarious influencing factors including anthropometric, social, economic anddemographic factors
3. To assess theadherence to lifestyle modification and Health-related qualityof life in post-angioplasty patients
**Source of datacollection and study material**
Patients will be recruitedfor this study if they have undergone coronary angioplasty. These patients willbe chosen after consideration of inclusion and exclusion criteria. Informedconsent will be taken from subjects. Collection of data including demographichistory, present medication, and different lab test reports along with ECG,Echo, coronary angiogram and angioplasty. As the study will be carried outprospectively, material and data will be collected during hospitalization andon follow up. Results will be documented in a customized form or form designedby an organization, containing complete details of patients medications andinvestigations. On discharge, patient will be asked to come for follow upon 1, 6, 12, 18 and 24 months with proper instruction and standard counselingabout the risk factors, life style modification and awareness about need forlong term therapy (Drug compliance) for prevention of [recurrentevents](http://en.wikipedia.org/wiki/Relapse "Relapse") and [complications](http://en.wikipedia.org/wiki/Complication_(medicine) "Complication (medicine)"). On each follow up we willdocument the blood pressure and blood test reports of the patients. There willbe assessment of MACE and angina by history and tests like ECG, Echo, TMT andrepeat CAG, if needed .We will also assess the base line characteristicsincluding co-morbidities, and anthropometry measurements. We will also note anychange of medications done on follow up, as well as enquire about quality oflife according to WHO Quality of Life questionnaire. After completion ofpatient’s data collection, entry will be done and data will be analyzed to getresults. After the completion of study, documentation and reportingwill be done according to protocol.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 1000
- South Indian Patients of both gender aged between 18-65 years who undergo coronary angioplasty.
- Patients who agreed and consented to participate in the study.
- Patients with moderate or severe LV dysfunction, EF less than 40 percent.
- Cardiogenic shock on presentation/ during hospitalization.
- Patients with Chronic Kidney Disease.
- Patients with proven Psychiatric illness on medications.
- Patients whose viral markers positive.
- Pregnant women 7.
- Terminal malignancy patients with life expectancy less than one year.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite of Major Adverse Cardiac Events From the day of discharge to 24 months of follow up
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Kasturba Medical College
🇮🇳Udupi, KARNATAKA, India
Kasturba Medical College🇮🇳Udupi, KARNATAKA, IndiaDr Prasad ShettyPrincipal investigator9964026792dr.prasadnshetty@gmail.com