Determinant of Repeat Revascularization After Percutaneous Coronary Intervention
Determinant of Repeat Revascularization Within 5 Years of Percutaneous Coronary Intervention at a Tertiary Care Hospital, Karachi: A Matched Case-Control Study
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Sindh
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Karachi, Sindh, Pakistan, 74800
- Aga Khan University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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.
|
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.
|
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
Sponsor
Investigators
- Principal Investigator: Komal Valliani, BScN, MScEB, Aga Khan University Karachi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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
Studies a U.S. FDA-regulated device product
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