Determinant of Repeat Revascularization After Percutaneous Coronary Intervention

Sponsor

Aga Khan University (Other)

Overall Status

Completed

CT.gov ID

NCT05189249

Collaborator

(none)

270

Enrollment

Location

Actual Duration (Months)

22.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Percutaneous Coronary Intervention Coronary Artery Disease	Other: No intervention performed

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 Design

Study Type:

Observational

Actual Enrollment :

270 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Repeat Revascularization [January 2018 to December 2018]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aga Khan University	Karachi	Sindh	Pakistan	74800

Sponsors and Collaborators

Aga Khan University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Komal Valliani, Ms, Aga Khan University

ClinicalTrials.gov Identifier:

NCT05189249

Other Study ID Numbers:

5004-CHS-ERC-17

First Posted:

Jan 12, 2022

Last Update Posted:

Jan 12, 2022

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Komal Valliani, Ms, Aga Khan University

Repeat revascularization, Percutaneous Coronary Intervention, Coronary Artery Disease.

Additional relevant MeSH terms:

Coronary Artery Disease

Myocardial Ischemia

Coronary Disease

Study Results

No Results Posted as of Jan 12, 2022