Ischemic Heart Disease
Conditions
Keywords
Coronary Artery Disease, Fractional Flow Reserve, Dobutamine Stress Echocardiography, Stable Coronary Artery Disease, Bystander Coronary Artery Disease, Non-Culprit Lesions, Acute Myocardial Infarction
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.
Interventions
PROCEDURERevascularisation
Percutaneous coronary intervention or coronary artery bypass surgery
OTHEROptimal Medical Treatment/OMT
Standard of care in stable coronary artery disease or after acute myocardial infarction.
Sponsors
Semmelweis University Heart and Vascular Center
Bajcsy-Zsilinszky Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Myocardial Infarction | 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 |
| Target Vessel Revascularisation | From baseline to at least 2 years | The Investigated Vessel need Revascularisation because of at least Canadian Cardiology Society Angina Class III |
| Cardiovascular Death | From baseline to at least 2 years | Death occurs due to Cardiovascular cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Angina | From baseline to at least 2 years | Rehospitalisation due to Angina |
| Non-Target Vessel Revascularisation | From baseline to at least 2 years | The Non-Investigated Vessel need Revascularisation |
| Heart failure | From baseline to at least 2 years | Rehospitalisation due to Heart Failure |
| Non-Cardiac Death | From baseline to at least 2 years | Death occurs due to Non-Cardiovascular cause |
Outcome results
None listed