Coronary Microvascular DiseaseMICRO-SNAPENCT06125392
Multicenter Registry on Microvascular Dysfunction - Searching a New Ach Spasm Definition
An observational study of Coronary Microvascular Disease and Coronary Vasospasm, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
The MICRO-SNAPE registry will collect data from patients undergoing investigation of microvascular dysfunction and coronary spasm in Europe and North America. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Microvascular Disease, Coronary Vasospasm
- What is being tested?
- Coronary physiology assessment
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 30 Sep 2023to 31 Aug 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with angina but no epicardial disease.
Who may be able to join
- 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.
Who cannot join
- Hemodynamic instability
- Age <18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Center of Cardiology, Cardiology I, university hospital Mainz
Mainz, Rhineland-Palatinate, 55131
Tommaso Gori, Prof Dr, PhD, +49 (0) 6131 17 2729, tommaso.gori@unimedizin-mainz.de
Tommaso Gori, Prof Dr, PhD
About this study
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
The MICRO-SNAPE registry will collect data from patients undergoing investigation of microvascular dysfunction and coronary spasm in Europe and North America.
Read the 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.
- Conditions
- Coronary Microvascular Disease, Coronary Vasospasm
- Being tested
- Coronary physiology assessment
- Medical subject headings
- Microvascular Angina, Coronary Vasospasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary physiology assessmentDiagnostic test
Also called Parameters of coronary physiology in response to microvascular vasodilators (adenosine, papaverine) and acetylcholine
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.
| Study group | Role | What they receive |
|---|---|---|
| Invasive assessment of coronary vasomotor function | All lesions undergoing assessment of coronary microvascular dysfunction and coronary spasm using coronary pressure wires. Receives: Diagnostic Test: Coronary physiology assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately after the invasive measurement
Secondary outcomes (6)
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
Measured: immediately after the invasive measurement
Normal values expressing endothelium-dependent coronary flow reserve
Acetylcholine-induced coronary flow reserve in subjects without microvascular dysfunction.
Measured: immediately after the invasive measurement
Sex impact on coronary vasospasm measures
Difference between males and females in microvascular and epicardial spasm measures
Measured: immediately after the invasive measurement
Coronary bridge and epicardial spasm
Impact of coronary brudge on the incidence of epicaridal spasm
Measured: immediately after the invasive measurement
Acetylcholine versus adenosine responses
Comparison of adenosine- versus acetylcholin-induced microvascular dilatation (IMR)
Measured: immediately after the invasive measurement
Normal values and associations of resting microvascular resistances
We will assess the normal values of resting microvascular resistances using a frequentistic approach and study their associations with comorbidities and clinical parameters.
Measured: Immediately upon measurment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start30 Sep 2023
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Microvascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tommaso Gori, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125392
- Sponsor's protocol ID
- UM 20-0274
- Acronym
- MICRO-SNAPE
- Status last verified
- Oct 2024
- First submitted
- 26 Sep 2023
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon legitimate request
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06125392
- Acronym / sponsor ID
- MICRO-SNAPE / UM 20-0274
- Conditions
- Coronary Microvascular Disease, Coronary Vasospasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Invasive assessment of coronary vasomotor function | – | Diagnostic Test: Coronary physiology assessmentAll lesions undergoing assessment of coronary microvascular dysfunction and coronary spasm using coronary pressure wires. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with angina but no epicardial disease.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Hemodynamic instability
- Age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary physiology assessmentAlso: Parameters of coronary physiology in response to microvascular vasodilators (adenosine, papaverine) and acetylcholineResting 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. | Diagnostic test | Invasive assessment of coronary vasomotor function |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Individual participant dataSharing planned: Undecided. Upon legitimate request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Center of Cardiology, Cardiology I, university hospital Mainz
Mainz, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Microvascular Disease and Coronary Vasospasm, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of endotypes of coronary vasomotor function (time frame: immediately after the invasive measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024; AzTrials last refreshed its copy on 28 Oct 2026.