Clinical Outcomes of Patients With Deferred Revascularization Based on FFR and iFR Negative Coronary Artery Lesions.

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05240768
• Other study ID #: 2020-3681-10742
• Status: Completed
• Start date: January 10, 2020
• Est. completion date: August 20, 2021

Study information

• Verified date: February 2022
• Source: Aga Khan University Hospital, Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: August 20, 2021
• Est. primary completion date: June 1, 2021
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Diagnostic Test:
• Fractional flow reserve, instantaneous wave-free Ratio
Clinical outcomes observed for patients with moderate coronary lesions in whom coronary revascularization was deferred due to a negative physiologic study.

Locations

Country	Name	City	State
Pakistan	Aga Khan University Hospital	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University Hospital, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac death	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	29 months
Primary	Non-fatal myocardial infarction	Number of patients suffering from Myocardial infarction but did not die.	29 months
Primary	Target vessel revascularization.	Repeat PCI or bypass graft placement for a stenosis in another part of the vessel treated at the index PCI	29 months