DSE vs. FFR in SCAD and BYSTANDER Lesions (DSE-vs-FFR)

December 27, 2019 updated by: Peter Andrassy MD.PhD., Bajcsy-Zsilinszky Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Easy accessibility made fractional flow reserve (FFR) a widely accepted method to evaluate myocardial ischaemia in patients with moderate coronary artery stenosis, although the prognostic value for "hard" endpoints such as myocardial infarction and cardiovascular death is equivocal.

Dobutamine stress echocardiography (DSE) is a useful and safe non-invasive functional test for myocardial ichaemia evaluation. There are robust data confirming the prognostic value of DSE regarding the same "hard" endpoints.

In patients with SCAD there are clear recommendations in the recent guidelines both for DSE guided or FFR guided revascularization but the data about prognosis is limited, especially in the case of FFR guidance. The outcome is also equivocal if there is a difference between the invasive and non-invasive test result.

In patients with acute myocardial infarction, more than 50% of patients have multivessel disease. There are clear recommendations for the management of infarct related artery, however controversy still exists for the management of angiographically moderate NCLs.

In DSE vs. FFR prospective trial, the Investigators plan to perform both the DSE and FFR tests in the above mentioned clinical settings, to investigate the correlation between them. The causes of differences between them would be investigated as well as the prognostic impact of reclassification by a second test (either DSE or FFR).

If both tests are positive, revascularisation is planned to be performed (PCI Group). In cases of either double negative or mismatching tests, optimal medical therapy will be chosen (OMT Group) with clinical follow up of at least 2 years.

Study Type

Observational

Enrollment (Actual)

200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

In this study, the suitable patients have at least one moderate coronary artery stenosis identified by coronary angiography.

There will be patients with stable coronary artery disease and patients with acute myocardial infarction having at least one non-culprit vessel stenoses.

Description

Inclusion Criteria:

  • Age>18 years
  • Moderate Coronary Stenosis (30-70 %)
  • Stable coronary artery disease or patients with acute myocardial infarction and at least one moderate non-culprit vessel stenosis

Exclusion Criteria:

  • Left Main Coronary artery stenosis
  • Age>80 years
  • Known non-cardiovascular disease with poor prognosis
  • Patients for whom coronary angiography or stress echocardiography is contraindicated per institutional standard of care (e.g. History of severe and/or anaphylactic contrast reaction)
  • Inability to provide informed consent;
  • Inability to cooperate with the investigation
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DSE+/FFR+
Patients with positive Dobutamine Stress Echocardiography and with positive Fractional Flow Reserve Revascularisation
Procedure: Revascularisation
Percutaneous coronary intervention or coronary artery bypass surgery
Other Names:
  • PCI or CABG
DSE+/FFR- or DSE-/FFR+ or DSE-/FFR-

Patients with positive Dobutamine Stress Echocardiography and with negative Fractional Flow Reserve

Patients with negative Dobutamine Stress Echocardiography and with positive Fractional Flow Reserve

Patients with negative Dobutamine Stress Echocardiography and with negative Fractional Flow Reserve

Optimal Medical Treatment/OMT
Other: Optimal Medical Treatment/OMT
Standard of care in stable coronary artery disease or after acute myocardial infarction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Myocardial Infarction
Time Frame: From baseline to at least 2 years

Detection of a rise and/or fall of cardiac biomarker values [preferably cardiac troponin (cTn)] with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following: Symptoms of ischaemia. New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB).

Development of pathological Q waves in the ECG. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.

Identification of an intracoronary thrombus by angiography or autopsy
From baseline to at least 2 years
Target Vessel Revascularisation
Time Frame: From baseline to at least 2 years
The Investigated Vessel need Revascularisation because of at least Canadian Cardiology Society Angina Class III
From baseline to at least 2 years
Cardiovascular Death
Time Frame: From baseline to at least 2 years
Death occurs due to Cardiovascular cause
From baseline to at least 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Angina
Time Frame: From baseline to at least 2 years
Rehospitalisation due to Angina
From baseline to at least 2 years
Heart failure
Time Frame: From baseline to at least 2 years
Rehospitalisation due to Heart Failure
From baseline to at least 2 years
Non-Cardiac Death
Time Frame: From baseline to at least 2 years
Death occurs due to Non-Cardiovascular cause
From baseline to at least 2 years
Non-Target Vessel Revascularisation
Time Frame: From baseline to at least 2 years
The Non-Investigated Vessel need Revascularisation
From baseline to at least 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bajcsy-Zsilinszky Hospital

Collaborators

Semmelweis University Heart and Vascular Center

Investigators

  • Principal Investigator: Péter Andrássy, MD.PhD., Bajcsy-Zsilinszky Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

December 19, 2017

First Submitted That Met QC Criteria

December 19, 2017

First Posted (Actual)

December 26, 2017

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 27, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Results will be shared ONLY with the patient's other physicians.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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