Determinant of Repeat Revascularization After Percutaneous Coronary Intervention

NCT ID: NCT05189249

Last Updated: 2023-07-24

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

270 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-12-31

Brief Summary

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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

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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).

Conditions

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Percutaneous Coronary Intervention Coronary Artery Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

Intervention Type OTHER

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

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Aged 25 years and older
* 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

* 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.


* If suffering from any hypercoagulable disorder.
Minimum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Aga Khan University

OTHER

Sponsor Role lead

Responsible Party

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Komal Valliani

Principal Investigator

Responsibility Role 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

Site Status

Countries

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Pakistan

Other Identifiers

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5004-CHS-ERC-17

Identifier Type: -

Identifier Source: org_study_id

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