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RecruitingNCT06125392MICRO-SNAPEUpdated Nov 1, 2024

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

An observational study in Coronary Microvascular Disease and Coronary Vasospasm, sponsored by Johannes Gutenberg University Mainz. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-11-01.

Sponsored by Johannes Gutenberg University Mainz · Observational

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
1,000
Ages
18 Years to 90 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Coronary Microvascular Disease
  • Coronary Vasospasm
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In context

Microvascular Angina

111 studies on the registry are indexed under Microvascular Angina; 39 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 200 across 46 observational studies indexed under Microvascular Angina.

Browse Microvascular Angina studies →

Lead sponsor

Johannes Gutenberg University Mainz is the lead sponsor of 156 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with angina but no epicardial disease.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Hemodynamic instability
  • Age \<18 years
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
1,000 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • Invasive assessment of coronary vasomotor function

    All lesions undergoing assessment of coronary microvascular dysfunction and coronary spasm using coronary pressure wires.

    Diagnostic Test: Coronary physiology assessment

Interventions

  • Diagnostic testCoronary 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.

    Also known as: Parameters of coronary physiology in response to microvascular vasodilators (adenosine, papaverine) and acetylcholine

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What researchers measure

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 measurement

Secondary 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 measurement

  2. Normal values expressing endothelium-dependent coronary flow reserve

    Acetylcholine-induced coronary flow reserve in subjects without microvascular dysfunction.

    Time frame: immediately after the invasive measurement

  3. Sex impact on coronary vasospasm measures

    Difference between males and females in microvascular and epicardial spasm measures

    Time frame: immediately after the invasive measurement

  4. Coronary bridge and epicardial spasm

    Impact of coronary brudge on the incidence of epicaridal spasm

    Time frame: immediately after the invasive measurement

  5. Acetylcholine versus adenosine responses

    Comparison of adenosine- versus acetylcholin-induced microvascular dilatation (IMR)

    Time frame: immediately after the invasive measurement

  6. 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.

    Time frame: Immediately upon measurment

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided — Upon legitimate request

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2023 (actual). Primary completion is estimated for Aug 2028, 59 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 26, 2023
First posted
Nov 9, 2023
StartActual
Sep 30, 2023
Primary completionEst.
Aug 31, 2028
CompletionEst.
Aug 31, 2028
Last update
Nov 1, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06125392
Responsible party
Tommaso Gori (Professor, Johannes Gutenberg University Mainz) — Principal investigator
First posted
Nov 9, 2023
Start date
Sep 30, 2023
Primary completion
Aug 31, 2028 (estimated)
Completion
Aug 31, 2028 (estimated)
Last update
Nov 1, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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