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

NCT05240768 | Completed

• 1 other identifier: 2020-3681-10742
• Study Type: observational
• Target: 345
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (3)

• 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

• Non-fatal myocardial infarction

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

  29 months

• 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

Interventions

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.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mean age of study population was 62 ±11 years and majority (71%) of the population was male.76% (263) of the population was hypertensive, diabetes mellitus and dyslipidemia was present in 49%(169) and 53%(185) respectively. History of myocardial infarction (MI) was present in 12% (43) and one-fourth of population had history of revascularization, i.e PCI (19%) or coronary artery bypass grafting(CABG) 3%.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aga Khan University Hospital, Pakistan: lead

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, Section of Cardiology, Department of Medicine

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: February 15, 2022
• Study Start: January 10, 2020
• Primary Completion: June 1, 2021
• Study Completion: August 20, 2021
• Last Updated: February 15, 2022

Record last verified: 2022-02

Locations

PA (1)