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

NCT ID: NCT06125392

Last Updated: 2024-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-30

Study Completion Date

2028-08-31

Brief Summary

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The MICRO-SNAPE registry will collect data from patients undergoing investigation of microvascular dysfunction and coronary spasm in Europe and North America.

Detailed Description

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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

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Coronary Microvascular Disease Coronary Vasospasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Invasive assessment of coronary vasomotor function

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

Coronary physiology assessment

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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Coronary 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

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Tommaso Gori

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Center of Cardiology, Cardiology I, university hospital Mainz

Mainz, Rhineland-Palatinate, Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Tommaso Gori, Prof Dr, PhD

Role: primary

+49 (0) 6131 17 2729

Tommaso Gori, Prof Dr, PhD

Role: backup

Other Identifiers

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UM 20-0274

Identifier Type: -

Identifier Source: org_study_id

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