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DSE vs. FFR in SCAD and BYSTANDER Lesions

NCT03383718 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2020-01-02

No results posted yet for this study

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

Conditions

  • Ischemic Heart Disease

Interventions

PROCEDURE

Revascularisation

Percutaneous coronary intervention or coronary artery bypass surgery

OTHER

Optimal Medical Treatment/OMT

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

Sponsors & Collaborators

  • Semmelweis University Heart and Vascular Center

    collaborator OTHER

  • Bajcsy-Zsilinszky Hospital

    lead OTHER

Principal Investigators

  • Péter Andrássy, MD.PhD. · Bajcsy-Zsilinszky Hospital

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-01
Primary Completion
2017-12-01
Completion
2019-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03383718 on ClinicalTrials.gov