About this trial
This is a single-center, prospective interventional study evaluating noninvasive coronary function testing using transthoracic Doppler echocardiography of the left anterior descending coronary artery in patients with stable angina and nonobstructive coronary artery disease (ANOCA) who previously underwent invasive coronary function testing (adenosine and/or acetylcholine).
A group of age- and sex-matched healthy volunteers will be enrolled to support interpretation of potentially abnormal noninvasive responses observed in patients.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age between 18 and 90 years;
ICA performed within the previous 12 months from enrollment and characterized by: (a) absence of obstructive CAD (<50% diameter reduction or FFR by >0.80); (b) invasive assessment of epicardial/microvascular spasm by acetylcholine test;
Signed informed consent.
Disqualifiers
Presentation as an acute coronary syndrome (i.e. unstable chest pain) or a typical history of variant angina (frequent angina pain at rest with ST-segment elevation at the ECG, caused by recurrent coronary spasm);
Previous coronary revascularization with surgical intervention;
Asthma or known intolerance or contraindications to dipyridamole;
Serious medical conditions, including renal failure (eGFR <30 mL/min), liver diseases, malignancies, and acute or chronic inflammatory diseases;
Trial design
Single group
Treatments tested in this trial
Coronary flow reserve assessed by Echocardiography
Diagnostic testAll patients and controls will undergo the following tests during transthoracic echocardiographic Doppler examination of the left anterior descending coronary artery, with time intervals of 30 minutes from each other: 1. hyperventilation test: the patient is asked to breathe at a rate of 30 respirations per minute, for 5 minutes; 2. cold pressor test: the patient puts his/her right hand in ice water for 2 minutes; 3. dipyridamole test: intravenous dipyridamole is administered at a dose of 0.84 mg/kg over 6 minutes; Peak diastolic velocity (PDV) of blood flow in the left anterior descending coronary artery will be measured before and at the end of each test by pulsed-wave Doppler, using a GE E95 echocardiographic machine. The ratio between peak flow velocity of coronary blood flow at peak of each test and the relative basal peak flow velocity of coronary blood flow is taken as the response of coronary blood flow velocity to each test.
Treatment groups
Trial outcomes
Primary outcomes
Correlation (Phi coefficient) between TTE-induced vasoconstriction and acetylcholine-induced spasm at invasive assessment.
The primary aim of the study is to investigate the usefulness of studying coronary flow reserve by transthoracic color Doppler echocardiogram in reaching the diagnosis of coronary vasomotor disturbance.
Secondary outcomes
Agreement between dipyridamole-induced non-invasive coronary flow reserve and invasive coronary flow reserve
Agreement between coronary flow reserve (CFR) measured by transthoracic echocardiography during dipyridamole stress and CFR measured during invasive coronary function testing. Unit of Measure: Pearson correlation coefficient
Agreement between cold pressor test-induced non-invasive coronary flow reserve and invasive coronary flow reserve
Agreement between coronary flow reserve (CFR) measured by transthoracic echocardiography during cold pressor test and CFR measured during invasive coronary function testing. Unit of Measure: Pearson correlation coefficient
Association between abnormal non-invasive coronary vasomotor response and angina symptoms
Comparison of Seattle Angina Questionnaire (SAQ) summary score between patients with abnormal versus normal coronary vasodilator response during stress echocardiography. Unit of Measure: SAQ summary score (0-100)
Locations
Sponsors and contacts
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