Non-invasive Evaluation of Patients With Angina and Non-obstructive Coronary Artery Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Coronary flow reserve assessed by Echocardiography

    Diagnostic test

    All 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

35 Participants
are divided into 2 treatment groups
Group A: Non-invasive coronary flow reserve in patients with ANOCAExperimental treatment 1 intervention
Group B: Non-invasive coronary flow reserve in healthy volunteersActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Periprocedural

Secondary outcomes

1

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

Time frame
Periprocedural
2

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

Time frame
Periprocedural
3

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)

Time frame
Periprocedural

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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