Non-invasive Evaluation of Patients With Angina and Non-obstructive Coronary Artery Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Coronary flow reserve assessed by Echocardiography.
- Who it may be relevant to
- Registry conditions: ANOCA - Angina With Non-obstructive Coronary Arteries. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Patients referred to the catheterization laboratory of Fondazione Policlinico Universitario A. Gemelli IRCCS for stable angina who show non-obstructive coronary artery disease at invasive coronary angiography and underwent invasive coronary function testing will be enrolled.
During a transthoracic echocardiographic Doppler examination of the left anterior descending coronary artery, participants will undergo three standardized stimuli (hyperventilation, cold pressor test, and dipyridamole) separated by 30-minute intervals, with peak diastolic velocity measured at baseline and at the end of each test.
For each stimulus, the coronary blood flow velocity response will be expressed as the ratio between peak and basal peak diastolic velocity.
Participants will also complete the Seattle Angina Questionnaire to assess symptom burden.
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 microcirculation dysfunction and/or coronary vasomotor disturbance.
The secondary aim of the study was to assess whether abnormalities on the stress echocardiogram with dipyridamole, hyperventilation, and cold-pressor test are related to the patient's symptoms.
Interventions
- Diagnostic test Coronary flow reserve assessed by Echocardiography
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
Primary outcome measures
- Correlation (Phi coefficient) between TTE-induced vasoconstriction and acetylcholine-induced spasm at invasive assessment. [Time frame: Periprocedural]
Secondary outcome measures (3)
- Agreement between dipyridamole-induced non-invasive coronary flow reserve and invasive coronary flow reserve [Time frame: Periprocedural]
- Agreement between cold pressor test-induced non-invasive coronary flow reserve and invasive coronary flow reserve [Time frame: Periprocedural]
- Association between abnormal non-invasive coronary vasomotor response and angina symptoms [Time frame: Periprocedural]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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;
- Pregnancy;
- Psychological conditions that might hamper patient co-operation;
- Any condition that, in the judgment of the investigators, would make difficult for the patient to complete the study protocol;
- Missed informed consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07422818 · 7363