Revascularisation
ProcedurePercutaneous coronary intervention or coronary artery bypass surgery
Other names: PCI or CABG
NCT Number: NCT03383718
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
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Notify Me18 year–80 year
All sexes
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Percutaneous coronary intervention or coronary artery bypass surgery
Other names: PCI or CABG
Standard of care in stable coronary artery disease or after 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
Time frame: From baseline to at least 2 years
The Investigated Vessel need Revascularisation because of at least Canadian Cardiology Society Angina Class III
Time frame: From baseline to at least 2 years
Death occurs due to Cardiovascular cause
Time frame: From baseline to at least 2 years
Rehospitalisation due to Angina
Time frame: From baseline to at least 2 years
Rehospitalisation due to Heart Failure
Time frame: From baseline to at least 2 years
Death occurs due to Non-Cardiovascular cause
Time frame: From baseline to at least 2 years
The Non-Investigated Vessel need Revascularisation
Bajcsy-Zsilinszky Hospital
Other
Comparison of Dobutamine Stress Echocardiography and Fractional Flow Reserve in Patients With Moderate Coronary Artery Disease: Stable and Non-culprit Lesions Investigation
Acronym: DSE-vs-FFR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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