Determinant of Repeat Revascularization After Percutaneous Coronary Intervention

Completed

• Conditions: Percutaneous Coronary Intervention; Coronary Artery Disease
• Interventions: Other: No intervention performed

• Registration Number: NCT05189249
• Lead Sponsor: Aga Khan University

Brief Summary

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.

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 Timeline

• Study Start: 2018-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Study First Submitted: 2021-12-28
• Study First Submitted QC: 2021-12-28
• Study First Posted: 2022-01-12
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 270

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	No intervention performed	Patients who have not undergone repeat revascularization within 5 years of undergoing index PCI at Aga Khan University Hospital Karachi.
Case	No intervention performed	Patients who have undergone repeat revascularization within 5 years of undergoing index PCI at Aga Khan University Hospital Karachi.

Primary Outcome Measures

Name	Time	Method
Factors associated with repeat revascularization	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).

Trial Locations

Locations (1)

Aga Khan University; 🇵🇰 Karachi, Sindh, Pakistan