Multicenter Registry on Microvascular Dysfunction - Searching a New Ach Spasm Definition
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Coronary physiology assessment.
- Who it may be relevant to
- Registry conditions: Coronary Microvascular Disease, Coronary Vasospasm. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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.
Primary outcome measures
- Identification of endotypes of coronary vasomotor function [Time frame: immediately after the invasive measurement]
Secondary outcome measures (6)
- Accuracy of clinical criteria for the diagnosis of microvascular and epicardial spasm [Time frame: immediately after the invasive measurement]
- Normal values expressing endothelium-dependent coronary flow reserve [Time frame: immediately after the invasive measurement]
- Sex impact on coronary vasospasm measures [Time frame: immediately after the invasive measurement]
- Coronary bridge and epicardial spasm [Time frame: immediately after the invasive measurement]
- Acetylcholine versus adenosine responses [Time frame: immediately after the invasive measurement]
- Normal values and associations of resting microvascular resistances [Time frame: Immediately upon measurment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Center of Cardiology, Cardiology I, university hospital Mainz — Mainz
Identifiers
NCT: NCT06125392 · UM 20-0274