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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06125392
Acronym
MICRO-SNAPE
Enrollment
1000
Registered
2023-11-09
Start date
2023-09-30
Completion date
2028-08-31
Last updated
2024-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Microvascular Disease, Coronary Vasospasm

Brief summary

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

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.

Sponsors

Johannes Gutenberg University Mainz
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Identification of endotypes of coronary vasomotor functionimmediately after the invasive measurementPatients will be classified in different endotypes according to the pattern of their responses to endothelium-dependent and independent vasodilators.

Secondary

MeasureTime frameDescription
Normal values expressing endothelium-dependent coronary flow reserveimmediately after the invasive measurementAcetylcholine-induced coronary flow reserve in subjects without microvascular dysfunction.
Sex impact on coronary vasospasm measuresimmediately after the invasive measurementDifference between males and females in microvascular and epicardial spasm measures
Accuracy of clinical criteria for the diagnosis of microvascular and epicardial spasmimmediately after the invasive measurementThe clinical criteria commonly used for the diagnosis of spasm (based on ECG and angina) will be validated against the benchmark invasive measurements
Acetylcholine versus adenosine responsesimmediately after the invasive measurementComparison of adenosine- versus acetylcholin-induced microvascular dilatation (IMR)
Normal values and associations of resting microvascular resistancesImmediately upon measurmentWe will assess the normal values of resting microvascular resistances using a frequentistic approach and study their associations with comorbidities and clinical parameters.
Coronary bridge and epicardial spasmimmediately after the invasive measurementImpact of coronary brudge on the incidence of epicaridal spasm

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026