CompREhensive Diagnostic Assessment of Coronary Endothelial Function Impairment and Vasospasm With CoNtinuous ThErmodilution in Patients With Suspected Coronary Microvascular and Vasomotor Dysfunction
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: Invasive coronary physiological measurements.
- Who it may be relevant to
- Registry conditions: Coronary Microvascular Dysfunction (CMD), Vasospasm, Coronary. 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
The goal of this observational study is to learn more about the diagnosis of coronary endothelium function and coronary vasospasm using a dedicated invasive protocol in patients who has angina without obstruction in their main heart arteries. The main question it aims to answer is the feasibility, reproducibility, and safety of this invasive protocol: Does this invasive protocol diagnose coronary endothelial dysfunction and vasospasm without issues? Participants already having invasive coronary angiogram and physiological studies will undergo additional physiological measurements during the same procedure. Participants will enrol in a symptoms and quality of life questionnaire using dedicated questionnaires and a mobile application to assess the burden of their symptoms before and after the invasive procedure and up to 12 months follow up. A subset of participants will undergo a repeat set of these measurements to assess reproducibility of the invasive protocol. A subset of the participants will also undergo a cardiac MRI to assess correlation with the invasive protocol measurements.
Interventions
- Procedure Invasive coronary physiological measurements
Invasive assessment of changes in coronary blood flow, resistance, and distal pressure in response to acetylcholine infusion. These will be measured during a clinical indicated invasive coronary angiogram procedure and physiological studies using a standard coronary pressure wire and a dedicated infusion catheter.
Primary outcome measures
- Feasibility outcome [Time frame: At baseline]
Secondary outcome measures (5)
- Reproducibility outcome [Time frame: At baseline]
- Safety outcome [Time frame: At Baseline and up to 12 months]
- Correlation between invasive and non-invasive measures of endothelial-dependent coronary microvascular dysfunction. [Time frame: From baseline and up to 3 months]
- Correlation between invasive physiological indices of coronary microvascular function and symptom burden at baseline. [Time frame: Baseline (at time of invasive coronary function testing).]
- Change in symptoms, quality of life, and need for further investigation or treatment during follow-up. [Time frame: From baseline to 12 months follow-up]
Eligibility criteria
Inclusion criteria
- Patients with symptoms suggestive of angina.
- Evidence of unobstructed coronary arteries on invasive or non-invasive coronary angiography (coronary stenosis <50% and /or FFR >0.80).
- Above the age of 18.
- The subject has been informed of the nature of the study, agrees to its provisions and has signed written informed consent.
Exclusion criteria
- Pregnancy.
- Contraindication to angiography and/or physiological assessment with adenosine or acetylcholine.
- Previous coronary artery bypass graft (CABG).
- Moderate to severe valvular heart disease.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07337005 · IRAS 356198