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

NCT06125392 | Recruiting DMC

• 1 other identifier: UM 20-0274
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Microvascular Disease; Coronary Vasospasm

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Accuracy of clinical criteria for the diagnosis of microvascular and epicardial spasm

  immediately after the invasive measurement

• Normal values expressing endothelium-dependent coronary flow reserve

  immediately after the invasive measurement

• Sex impact on coronary vasospasm measures

  immediately after the invasive measurement

• Coronary bridge and epicardial spasm

  immediately after the invasive measurement

• Acetylcholine versus adenosine responses

  immediately after the invasive measurement

Study Arms (1)

Invasive assessment of coronary vasomotor function

All lesions undergoing assessment of coronary microvascular dysfunction and coronary spasm using coronary pressure wires.

Diagnostic Test: Coronary physiology assessment

Interventions

Coronary physiology assessment DIAGNOSTIC_TEST

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.

Also known as: Parameters of coronary physiology in response to microvascular vasodilators (adenosine, papaverine) and acetylcholine

Invasive assessment of coronary vasomotor function

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with angina but no epicardial disease.

You may qualify if:

• 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.

You may not qualify if:

• Hemodynamic instability
• Age \<18 years

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

Center of Cardiology, Cardiology I, university hospital Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

RECRUITING

MeSH Terms

Conditions

Microvascular Angina; Coronary Vasospasm

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: November 9, 2023
• Study Start: September 30, 2023
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

DE (1)