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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05189249
Enrollment
270
Registered
2022-01-12
Start date
2018-01-01
Completion date
2018-12-31
Last updated
2023-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Percutaneous Coronary Intervention

Keywords

Repeat revascularization, Percutaneous Coronary Intervention, Coronary Artery Disease

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).

Interventions

No intervention performed. Participants were enrolled retrospectively and medical records were accessed for data.

Sponsors

Aga Khan University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Factors associated with repeat revascularizationJanuary 2018 to December 2018Identify 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).

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026