DSE vs. FFR in SCAD and BYSTANDER Lesions

NCT03383718 | Completed DMC

• 1 other identifier: 1.0
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Coronary Artery Disease; Fractional Flow Reserve; Dobutamine Stress Echocardiography; Stable Coronary Artery Disease; Bystander Coronary Artery Disease; Non-Culprit Lesions; Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (3)

• Acute Myocardial Infarction

  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

  The Investigated Vessel need Revascularisation because of at least Canadian Cardiology Society Angina Class III

  From baseline to at least 2 years

• Cardiovascular Death

  Death occurs due to Cardiovascular cause

  From baseline to at least 2 years

Secondary Outcomes (4)

• Angina

  From baseline to at least 2 years

• Heart failure

  From baseline to at least 2 years

• Non-Cardiac Death

  From baseline to at least 2 years

• Non-Target Vessel Revascularisation

  From baseline to at least 2 years

Study Arms (2)

DSE+/FFR+

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

Procedure: Revascularisation

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

Interventions

Revascularisation PROCEDURE

Percutaneous coronary intervention or coronary artery bypass surgery

Also known as: PCI or CABG

DSE+/FFR+

Optimal Medical Treatment/OMT OTHER

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

DSE+/FFR- or DSE-/FFR+ or DSE-/FFR-

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bajcsy-Zsilinszky Hospital: lead
• Semmelweis University Heart and Vascular Center: collaborator

Related Publications (22)

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MeSH Terms

Conditions

Myocardial Ischemia; Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Péter Andrássy, MD.PhD.

  Bajcsy-Zsilinszky Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lead of Cardiology Department

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: December 26, 2017
• Study Start: December 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share