Multicenter Registry on Microvascular Dysfunction - Searching a New Ach Spasm Definition (MICRO-SNAPE)

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

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

Study Overview

• Status: Recruiting
• Conditions: Coronary Vasospasm; Coronary Microvascular Disease
• Intervention / Treatment: Diagnostic test: Coronary physiology assessment

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 entered in this non-interventional registry.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• Germany
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Recruiting
      • Center of Cardiology, Cardiology I, university hospital Mainz
      • Contact: Tommaso Gori, Prof Dr, PhD; Phone Number: +49 (0) 6131 17 2729; Email: tommaso.gori@unimedizin-mainz.de
      • Principal Investigator: Tommaso Gori, Prof Dr, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with angina but no epicardial disease.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Invasive assessment of coronary masovomotor function; All lesions undergoing assessment of coronary microvascular dysfunction and coronary spasm using coronary pressure wires.

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.; Other Names: Parameters of coronary physiology in response to microvascular vasodilators (adenosine, papaverine) and acetylcholine

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2023
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: November 4, 2023
• First Posted (Estimated): November 9, 2023

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 4, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Angina Pectoris; Microvascular Angina; Coronary Vasospasm; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Peripheral Nervous System Agents; Cholinergic Agents; Urological Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Purinergic Agents; Cholinergic Agonists; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Agonists; Purinergic Agonists; Adenosine; Papaverine; Acetylcholine
• Other Study ID Numbers: UM 20-0274

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Upon legitimate request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No