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

Coronary Microvascular Disease Clinical Trial

— MICRO-SNAPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06125392
• Other study ID #: UM 20-0274
• Status: Recruiting
• Start date: September 30, 2023
• Est. completion date: August 31, 2028

Study information

• Verified date: June 2024
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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 entered in this non-interventional registry.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 31, 2028
• Est. primary completion date: August 31, 2028
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Microvascular Disease
• Coronary Vasospasm
• Microvascular Angina

Intervention

Diagnostic Test:
• Coronary physiology assessment
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.

Locations

Country	Name	City	State
Germany	Center of Cardiology, Cardiology I, university hospital Mainz	Mainz	Rheinland-Pfalz

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Normal values expressing endothelium-dependent vasodilation	Acetylcholine-induced microvascular resistance in subjects without microvascular dysfunction.	immediately after the invasive measurement
Secondary	Normal values expressing endothelium-dependent coronary flow reserve	Acetylcholine-induced coronary flow reserve in subjects without microvascular dysfunction.	immediately after the invasive measurement
Secondary	Sex impact on coronary vasospasm measures	Difference between males and females in microvascular and epicardial spasm measures	immediately after the invasive measurement
Secondary	Coronary bridge and epicardial spasm	Impact of coronary brudge on the incidence of epicaridal spasm	immediately after the invasive measurement
Secondary	Acetylcholine versus adenosine responses	Comparison of adenosine- versus acetylcholin-induced microvascular dilatation (IMR)	immediately after the invasive measurement
Secondary	Identification of endotypes of coronary vasomotor function	Patients will be classified in different endotypes according to the pattern of their responses to endothelium-dependent and independent vasodilators.	immediately after the invasive measurement