Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05189249 |
Other study ID # |
5004-CHS-ERC-17 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 1, 2018 |
Est. completion date |
December 31, 2018 |
Study information
Verified date |
July 2023 |
Source |
Aga Khan University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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).