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

NCT ID: NCT05240768

Last Updated: 2022-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

345 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-10

Study Completion Date

2021-08-20

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aga Khan University Hospital, Pakistan

OTHER

Sponsor Role lead

Responsible Party

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Jamshed Ali

Resident, Section of Cardiology, Department of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aga Khan University Hospital

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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2020-3681-10742

Identifier Type: -

Identifier Source: org_study_id

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