Multicenter Registry on Microvascular Dysfunction - Searching a New Ach Spasm Definition

Study Overview
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Brief Summary
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The MICRO-SNAPE registry will collect data from patients undergoing investigation of microvascular dysfunction and coronary spasm in Europe and North America.

Detailed Description
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Microvascular dysfunction is an important determinant of patients´quality of life and prognosis, which however remains poorly classified. Given the high burden of disease and the severity of the functional impairment in these patients, the lack of a clear understanding and diagnosis has a potentially large clinical importance. It is therefore important to better describe the phenotype of these patients. The MICRO-SNAPE registry will allow investigating these associations. Patient data as collected during the local clinical practice and at the operator's discretion, will be entered in this non-interventional registry.

Official Title
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A Multicenter regIstry on the Diagnosis of Patients With Chronic Angina and no Angiographic coRonary Artery Stenosis (International Retrospective Collection of Anonymized Patient Data) - Searching a New Ach Spasm Definition

Conditions
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Coronary Microvascular Disease, Coronary Vasospasm

Intervention / Treatment
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* Diagnostic Test: Coronary physiology assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who underwent combined measurements of coronary pressure and flow in at least 1 native coronary artery in response to endothelium dependent and independent vasodilators. Exclusion Criteria: Hemodynamic instability Age <18 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Invasive assessment of coronary masovomotor function<br>All lesions undergoing assessment of coronary microvascular dysfunction and coronary spasm using coronary pressure wires. | Diagnostic Test: Coronary physiology assessment<br>* Resting distal coronary to aortic pressure ratio, resting flow ratio, fractional flow reserve, Coronary Flow Reserve and Microvascular resistance using the thermodilution method and papaverin or adenosine, Resting distal coronary to aortic pressure ratio, resting flow ratio, fractional flow reserve, Coronary Flow Reserve and Microvascular resistance using the thermodilution method and acetylcholine.<br>* Other names: Parameters of coronary physiology in response to microvascular vasodilators (adenosine, papaverine) and acetylcholine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of clinical criteria for the diagnosis of microvascular and epicardial spasm | The clinical criteria commonly used for the diagnosis of spasm (based on ECG and angina) will be validated against the benchmark invasive measurements | immediately after the invasive measurement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normal values expressing endothelium-dependent vasodilation | Acetylcholine-induced microvascular resistance in subjects without microvascular dysfunction. | immediately after the invasive measurement | 
| Normal values expressing endothelium-dependent coronary flow reserve | Acetylcholine-induced coronary flow reserve in subjects without microvascular dysfunction. | immediately after the invasive measurement |