CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 enrolled
Drug / intervention
Revascularisation +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03383718
NCT03383718N/ACompleted

Comparison of Dobutamine Stress Echocardiography and Fractional Flow Reserve in Patients With Moderate Coronary Artery Disease: Stable and Non-culprit Lesions Investigation

Bajcsy-Zsilinszky Hospital·observational·Posted Dec 26, 2017·Updated Jan 2, 2020

In Brief

An observational study evaluating Revascularisation and Optimal Medical Treatment/OMT for Ischemic Heart Disease. Completed, enrolled 200 participants.

Detailed Summary

Enrollment: * Patients with stable coronary artery disease (SCAD) and moderate coronary artery stenoses (30-70 %) * Patients with acute myocardial infarction and moderate stenosis of non-culprit arteries (NCL; BYSTANDER LESION) Aims: * To assess the diagnostic accuracy of dobutamine stress echocardiography (DSE) and invasive fractional flow reserve (FFR) measurement * To assess the prognostic impact of reclassification by a mismatching negative test Hypothesis: * DSE and FFR have similar prognostic value in both clinical settings (SCAD and NCL) * Considering the strong negative predictive value of both DSE and FFR, one negative test is sufficiently enough to defer revascularisation, even in the case of mismatch

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 26, 2017
Enrollment StartDec 1, 2014
Primary CompletionDec 1, 2017
Study CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 8.5 years ago

Interventions

Revascularisationprocedure

Percutaneous coronary intervention or coronary artery bypass surgery

Optimal Medical Treatment/OMTother

Standard of care in stable coronary artery disease or after acute myocardial infarction.