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Clinical Trials/NCT05240768
NCT05240768
Completed
Not Applicable

Clinical Outcomes of Patients With Deferred Revascularization Based on Fractional Flow Reserve (FFR) and Instantaneous Wave-free Ratio (iFR) Negative Coronary Artery Lesions in Pakistani Population

Aga Khan University Hospital, Pakistan1 site in 1 country345 target enrollmentJanuary 10, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Aga Khan University Hospital, Pakistan
Enrollment
345
Locations
1
Primary Endpoint
Non-fatal myocardial infarction
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The objective is to assess long-term clinical outcomes of patients in whom intervention of coronary lesions was deferred due to negative fractional flow reserve (FFR) and negative Instantaneous wave-free ratio (iFR) in a real-world patient population and to identify factors associated with deferred target lesion failure.

Detailed Description

Fractional flow Reserve (FFR) evaluates functional significance of stenosis in intermediate coronary lesions. Instantaneous wave-free ratio (iFR) is considered noninferior to FFR and does not require adenosine administration. This study was done to assess long-term clinical outcomes and factors associated with target vessel revascularization (TVR) in patients with deferred revascularization based on negative FFR and iFR. Retrospective analysis of medical records of 345 patients with deferred revascularization at a tertiary care hospital , from January 2012 to January 2020 will be done.

Registry
clinicaltrials.gov
Start Date
January 10, 2020
End Date
August 20, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Aga Khan University Hospital, Pakistan
Responsible Party
Principal Investigator
Principal Investigator

Jamshed Ali

Resident, Section of Cardiology, Department of Medicine

Aga Khan University Hospital, Pakistan

Eligibility Criteria

Inclusion Criteria

  • Patients who had intermediate to severe coronary lesions on coronary angiogram.
  • Patients who had negative FFR \>0.80 or iFR \>0.89 and did not undergo immediate or planned revascularization on basis of negative physiologic assessment.

Exclusion Criteria

  • Patients younger than 18 years of age or those having positive FFR/iFR values irrespective of revascularization status were excluded.
  • Similarly, those who were lost to follow up and could not be traced via telephonic or were also excluded.

Outcomes

Primary Outcomes

Non-fatal myocardial infarction

Time Frame: 29 months

Number of patients suffering from Myocardial infarction but did not die.

Cardiac death

Time Frame: 29 months

Number of participants who died due to sudden cardiac arrest, sudden death due to acute MI and death due to heart failure or cardiogenic shock

Target vessel revascularization.

Time Frame: 29 months

Repeat PCI or bypass graft placement for a stenosis in another part of the vessel treated at the index PCI

Study Sites (1)

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