The clinical outcomes in Patients who have undergone PCI intervention - Observational Registry with an ambispective Component

INTRODUCTION:

Coronary artery disease (CAD) is a condition characterized by the narrowing or blockage of the coronary arteries, which supply blood to the heart muscle. CAD is usually caused by atherosclerosis, a build-up of plaque made up of cholesterol, fat, and other substances in the artery walls. Such plaque restricts blood flow to the heart and can lead to chest pain and myocardial infarction. Percutaneous coronary intervention (PCI) is one of the mainstay revascularization modalities in acute and chronic coronary artery diseases. Advancements in technique and technology have greatly improved the overall outcomes of PCI. There is a great need to assess the impact of various variables on the outcomes of PCI. Primary percutaneous coronary intervention (PCI) remains the cornerstone in the treatment by reducing the death rate in patients with acute myocardial infraction. A procedure registry, as a clinical data registry, is the result of a systematic process of data gathering, analysis, and storage that provides information about certain diagnostic or therapeutic

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rocedures. Such registries could help in measuring the effectiveness and quality of care, as well as monitoring the safety of procedures. Indeed, the cardiac procedure registry in Australia(1) led to early identification of outlier performance to ensure the maintenance of cardiac care standards and benchmarking of outcome data with feedback to clinicians and hospitals. Similarly, the deployment of the National Cardiovascular Data Registry (NCDR) in the United States resulted in better monitoring of cardiac procedures, comparison of diagnostic and therapeutic patterns in different settings, and assessment of the safety and performance of medical equipment used for cardiac procedures. The development of a PCI registry in collecting data and maintaining the standard of care comparable to global needs . This registry could help improve PCI outcomes and minimize complications of the PCI procedure. Improving data collection and processing approaches is necessary to build this registry efficiently and effectively. We aim to create a PCI registry at SRIHER to collect data effectively and to utilize it for all research purposes.

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STUDY DESIGN:

ï‚· Type of Study: Observational registry with an ambispective component

ï‚· Study Population: All patients who have undergone PCI at SRIHER from October 2016 or who will undergo PCI in future.[Retrospective cohort and Prospective cohort]

METHODS:

ï‚· This is an investigator-initiated registry to be performed by Department of Cardiology, Sri Ramachandra Institute of Higher Education and Research (SRIHER), Porur, Chennai.

ï‚· We will be collecting details of patients who have undergone percutaneous coronary intervention from October 2016 and who will undergo PCI.

ï‚· Patients’ details will be identified from the Cardiac Catheterization register and also from the Hospital patient database.

ï‚· Deidentified data including baseline characteristics, angiographic, and interventional details will be collected for the population.

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Inclusion Criteria

 Age ≥ 18 years old.

ï‚· Confirmed Patient who have undergone percutaneous coronary intervention

Exclusion Criteria

The patient refuses to give informed consent in the prospective cohort.

OUTCOMES:

Primary Outcomes: Major Adverse Cardiac Events (MACE) which in a composite event with death, MI and repeat target vessel revascularization .

Secondary outcome: Includes death and MI and repeat target vessel revascularization, stroke and Major Bleeding ( BAR>3 )

ETHICAL CONSIDERATIONS:

ï‚· Obtain approval from the Institutional Ethics committee

ï‚· Register the registry in CTRI