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

Recruiting

• Conditions: Coronary Microvascular Disease; Coronary Vasospasm
• Interventions: Diagnostic Test: Coronary physiology assessment

• Registration Number: NCT06125392
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief Summary

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

Detailed Description

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 retrospectively entered in this non-interventional registry in anonymous form.

Study Timeline

• Study First Submitted: 2023-09-26
• Study Start: 2023-09-30
• Study First Submitted QC: 2023-11-04
• Study First Posted: 2023-11-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01
• Primary Completion: 2028-08-31
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Invasive assessment of coronary masovomotor function	Coronary physiology assessment	All lesions undergoing assessment of coronary microvascular dysfunction and coronary spasm using coronary pressure wires.

Primary Outcome Measures

Name	Time	Method
Identification of endotypes of coronary vasomotor function	immediately after the invasive measurement	Patients will be classified in different endotypes according to the pattern of their responses to endothelium-dependent and independent vasodilators.

Secondary Outcome Measures

Name	Time	Method
Accuracy of clinical criteria for the diagnosis of microvascular and epicardial spasm	immediately after the invasive measurement	The clinical criteria commonly used for the diagnosis of spasm (based on ECG and angina) will be validated against the benchmark invasive measurements
Normal values expressing endothelium-dependent coronary flow reserve	immediately after the invasive measurement	Acetylcholine-induced coronary flow reserve in subjects without microvascular dysfunction.
Sex impact on coronary vasospasm measures	immediately after the invasive measurement	Difference between males and females in microvascular and epicardial spasm measures
Coronary bridge and epicardial spasm	immediately after the invasive measurement	Impact of coronary brudge on the incidence of epicaridal spasm
Acetylcholine versus adenosine responses	immediately after the invasive measurement	Comparison of adenosine- versus acetylcholin-induced microvascular dilatation (IMR)
Normal values and associations of resting microvascular resistances	Immediately upon measurment	We will assess the normal values of resting microvascular resistances using a frequentistic approach and study their associations with comorbidities and clinical parameters.

Trial Locations

Locations (1)

Center of Cardiology, Cardiology I, university hospital Mainz; 🇩🇪 Mainz, Rheinland-Pfalz, Germany