Determinant of Repeat Revascularization After Percutaneous Coronary Intervention
NCT ID: NCT05189249
Last Updated: 2023-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
270 participants
OBSERVATIONAL
2018-01-01
2018-12-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Case
Patients who have undergone repeat revascularization within 5 years of undergoing index PCI at Aga Khan University Hospital Karachi.
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.
No intervention performed
No intervention performed. Participants were enrolled retrospectively and medical records were accessed for data.
Interventions
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No intervention performed
No intervention performed. Participants were enrolled retrospectively and medical records were accessed for data.
Eligibility Criteria
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Inclusion Criteria
* Undergone repeat revascularization within 5 years of undergoing index PCI (from 2011 to 2017).
* Patients aged 25 years and older
* Undergone PCI once from the year 2011 to 2017.
Exclusion Criteria
* Revascularization procedure was per-formed outside the study setting
* Staged PCI within 3 weeks or planned PCI within 6 months of Index PCI.
* If suffering from any hypercoagulable disorder.
25 Years
FEMALE
No
Sponsors
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Aga Khan University
OTHER
Responsible Party
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Komal Valliani
Principal Investigator
Principal Investigators
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Komal Valliani, BScN, MScEB
Role: PRINCIPAL_INVESTIGATOR
Aga Khan University Karachi
Locations
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Aga Khan University
Karachi, Sindh, Pakistan
Countries
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Other Identifiers
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5004-CHS-ERC-17
Identifier Type: -
Identifier Source: org_study_id
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