Center of Cardiology, Cardiology I, university hospital Mainz
Mainz, Rhineland-Palatinate, 55131, Germany
Location status: Recruiting
Location contact
Tommaso Gori, Prof Dr, PhD
CONTACT
Tommaso Gori, Prof Dr, PhD
CONTACT
Recruiting
NCT Number: NCT06125392
Multicenter Registry on Microvascular Dysfunction - 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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–90 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
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.
Other names: Parameters of coronary physiology in response to microvascular vasodilators (adenosine, papaverine) and acetylcholine
Primary outcomes
-
Identification of endotypes of coronary vasomotor function
Time frame: immediately after the invasive measurement
Patients will be classified in different endotypes according to the pattern of their responses to endothelium-dependent and independent vasodilators.
Secondary outcomes
-
Accuracy of clinical criteria for the diagnosis of microvascular and epicardial spasm
Time frame: immediately after the invasive measurement
The clinical criteria commonly used for the diagnosis of spasm (based on ECG and angina) will be validated against the benchmark invasive measurements
-
Normal values expressing endothelium-dependent coronary flow reserve
Time frame: immediately after the invasive measurement
Acetylcholine-induced coronary flow reserve in subjects without microvascular dysfunction.
-
Sex impact on coronary vasospasm measures
Time frame: immediately after the invasive measurement
Difference between males and females in microvascular and epicardial spasm measures
-
Coronary bridge and epicardial spasm
Time frame: immediately after the invasive measurement
Impact of coronary brudge on the incidence of epicaridal spasm
-
Acetylcholine versus adenosine responses
Time frame: immediately after the invasive measurement
Comparison of adenosine- versus acetylcholin-induced microvascular dilatation (IMR)
-
Normal values and associations of resting microvascular resistances
Time frame: Immediately upon measurment
We will assess the normal values of resting microvascular resistances using a frequentistic approach and study their associations with comorbidities and clinical parameters.
Sponsors and collaborators
Lead sponsor
Johannes Gutenberg University Mainz
Other
Registry information
Official study 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
Acronym: MICRO-SNAPE
Important dates
- Study start
- 2023
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Nov 9, 2023
- Registry last updated
- Nov 1, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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