Multicenter Registry on Microvascular Dysfunction - Searching a New Ach Spasm Definition
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorJohannes Gutenberg University Mainz
About this trial
The MICRO-SNAPE registry will collect data from patients undergoing investigation of microvascular dysfunction and coronary spasm in Europe and North America.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Hemodynamic instability
Age <18 years
Trial population
Patients with angina but no epicardial disease.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Coronary physiology assessment
Diagnostic testResting 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.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Invasive assessment of coronary vasomotor function1 intervention
Trial outcomes
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.
Time frame
immediately after the invasive measurementSecondary outcomes
1
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
Time frame
immediately after the invasive measurement2
Normal values expressing endothelium-dependent coronary flow reserve
Acetylcholine-induced coronary flow reserve in subjects without microvascular dysfunction.
Time frame
immediately after the invasive measurement3
Sex impact on coronary vasospasm measures
Difference between males and females in microvascular and epicardial spasm measures
Time frame
immediately after the invasive measurement4
Coronary bridge and epicardial spasm
Impact of coronary brudge on the incidence of epicaridal spasm
Time frame
immediately after the invasive measurementSponsors and contacts
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Source ClinicalTrials.gov