Determinant of Repeat Revascularization After Percutaneous Coronary Intervention

July 21, 2023 updated by: Komal Valliani, Aga Khan University

Determinant of Repeat Revascularization Within 5 Years of Percutaneous Coronary Intervention at a Tertiary Care Hospital, Karachi: A Matched Case-Control Study

To determine factors associated with repeat revascularization among adults aged 25 years and above within 5 years of first Percutaneous Coronary Intervention (PCI) at a tertiary care hospital.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Matched case-control study design was employed to determine the association between re-peat revascularization and its determinants in patients within 5 years of undergoing index PCI. The case was defined as a patient who had undergone repeat revascularization within 5 years of undergoing index PCI. Control was defined as a patient who had not undergone repeat revascularization within 5 years of undergoing index PCI.

The retrospective study was carried out with the approval of the Ethical Review Committee of the tertiary care hospital where the study was carried out. A waiver of informed consent was granted as this was a retrospective study and all patients were discharged from the hospital.

A minimum of 120 cases with matched 240 controls were required in 1:2 case to control ratio. This sample size was essential to achieve the power of 80% for an anticipated matched odds ratio of 2 with the hypothesized correlation of 0.2 using a two-sided hypothesis test with a significance level of 0.05.

The outcome of the study was the Repeat revascularization status. There are different types of repeat revascularization according to the site and lesion to which intervention has been provided. Any type of repeat revascularization was considered and enrolled as a case in this study5.

Covariates included in the study were divided into patient characteristics (gender, age, health coverage, BMI, smoking status), comorbidity status (Hypertension, Diabetes Mellitus, Hyperlipidaemia, valvular disease), clinical characteristics (Creatinine level, Systolic Blood Pressure, Diastolic Blood Pressure, HbA1c, Cholesterol level, other technical factors related to the index PCI) and medication status (Beta-blocker, ACE Inhibitor, Statin).

Study Type

Observational

Enrollment (Actual)

270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74800
        • Aga Khan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The target population includes all the adult patients age 25 years and above who were revascularized at least at the Aga Khan University Hospital, Karachi.

Description

Inclusion Criteria for Cases:

  • Aged 25 years and older
  • Undergone repeat revascularization within 5 years of undergoing index PCI (from 2011 to 2017).

Exclusion Criteria for Cases:

  • If suffering from any hypercoagulable disorder
  • Revascularization procedure was per-formed outside the study setting
  • Staged PCI within 3 weeks or planned PCI within 6 months of Index PCI.

Inclusion Criteria for Controls:

  • Patients aged 25 years and older
  • Undergone PCI once from the year 2011 to 2017.

Exclusion Criteria for Controls:

  • If suffering from any hypercoagulable disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case
Patients who have undergone repeat revascularization within 5 years of undergoing index PCI at Aga Khan University Hospital Karachi.
Other: No intervention performed
No intervention performed. Participants were enrolled retrospectively and medical records were accessed for data.
Control
Patients who have not undergone repeat revascularization within 5 years of undergoing index PCI at Aga Khan University Hospital Karachi.
Other: No intervention performed
No intervention performed. Participants were enrolled retrospectively and medical records were accessed for data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factors associated with repeat revascularization
Time Frame: January 2018 to December 2018
Identify factors that are associated with repeat coronary intervention in the form of PCI or CABG once patient has been discharged after index PCI and during follow-up years (excluding staged PCI planned within three weeks of index PCI).
January 2018 to December 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Investigators

  • Principal Investigator: Komal Valliani, BScN, MScEB, Aga Khan University Karachi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

December 28, 2021

First Submitted That Met QC Criteria

December 28, 2021

First Posted (Actual)

January 12, 2022

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5004-CHS-ERC-17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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