Comparison of Dobutamine Stress Echocardiography and Fractional Flow Reserve in Patients With Moderate Coronary Artery Disease: Stable and Non-culprit Lesions Investigation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ischemic Heart Disease
- Sponsor
- Bajcsy-Zsilinszky Hospital
- Enrollment
- 200
- Primary Endpoint
- Acute Myocardial Infarction
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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
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.
Investigators
Peter Andrassy MD.PhD.
Clinical Lead of Cardiology Department
Bajcsy-Zsilinszky Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
Cardiovascular Death
Time Frame: From baseline to at least 2 years
Death occurs due to Cardiovascular cause
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
Secondary Outcomes
- Angina(From baseline to at least 2 years)
- Heart failure(From baseline to at least 2 years)
- Non-Target Vessel Revascularisation(From baseline to at least 2 years)
- Non-Cardiac Death(From baseline to at least 2 years)