DSE vs. FFR in SCAD and BYSTANDER Lesions
Condition: Ischemic Heart Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Heart Diseases
Study type: Observational

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.
    

Intervention name(s): Revascularisation; Optimal Medical Treatment/OMT
Intervention type(s): Procedure; Other
Intervention description(s): Percutaneous coronary intervention or coronary artery bypass surgery; Standard of care in stable coronary artery disease or after acute myocardial infarction.
Other intervention name(s): PCI or CABG
Observational model: Cohort
Time perspective: Prospective
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.
      
Keywords: Coronary Artery Disease; Fractional Flow Reserve; Dobutamine Stress Echocardiography; Stable Coronary Artery Disease; Bystander Coronary Artery Disease; Non-Culprit Lesions; Acute Myocardial Infarction