Assessment of factors associated with major adverse cardiac events after undergoing percutaneous transluminal coronary angioplasty.

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 and complications. 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.