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Completed

NCT Number: NCT05240768

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Aga Khan University Hospital

Karachi, Sindh, Pakistan

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fractional flow reserve, instantaneous wave-free Ratio

Diagnostic Test

Clinical outcomes observed for patients with moderate coronary lesions in whom coronary revascularization was deferred due to a negative physiologic study.

Primary outcomes

  1. 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

  2. Non-fatal myocardial infarction

    Time frame: 29 months

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

  3. 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

Sponsors and collaborators

Lead sponsor

Aga Khan University Hospital, Pakistan

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 15, 2022
Registry last updated
Feb 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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