NCT05189249

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 12, 2022

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

12 months

First QC Date

December 28, 2021

Last Update Submit

July 21, 2023

Conditions

Keywords

Repeat revascularizationPercutaneous Coronary InterventionCoronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Factors associated with repeat revascularization

    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

Study Arms (2)

Case

Patients who have undergone repeat revascularization within 5 years of undergoing index PCI at Aga Khan University Hospital Karachi.

Other: No intervention performed

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

Interventions

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

CaseControl

Eligibility Criteria

Age25 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The target population includes all the adult patients age 25 years and above who were revascularized at least at the Aga Khan University Hospital, Karachi.

You may qualify if:

  • Aged 25 years and older
  • Undergone repeat revascularization within 5 years of undergoing index PCI (from 2011 to 2017).

You may not qualify if:

  • 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.
  • Patients aged 25 years and older
  • Undergone PCI once from the year 2011 to 2017.
  • If suffering from any hypercoagulable disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Komal Valliani, BScN, MScEB

    Aga Khan University Karachi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 28, 2021

First Posted

January 12, 2022

Study Start

January 1, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

July 24, 2023

Record last verified: 2023-07

Locations