Mainz Intracoronary Database. The Coronary Slow-flow and Microvascular Diseases Registry

Recruiting

• Conditions: Coronary Artery Disease; Microvascular Dysfunction
• Interventions: Other: observational only- no intervention

• Registration Number: NCT02180178
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief Summary

Primary goal of the registry is to collect prospective data on patients undergoing coronary angiography in Mainz. Following amendment of the procol, this study will also include patients who received an Aborb bioresorbable scaffold for the therapy of de novo stenoses.

Detailed Description

Patients included in the registry will be contacted by telephone at 3,6,9, 12 months and 2, 5, 10 years after the procedure. In case coronary slow flow is shown at the index procedure, 39ml of blood will be drawn for further studies.

According to the regulations of the Province Rheinland-Pfalz, national law, and with the approval of the Ethic commission of the Landesärztekammer Rheinland Pfalz, patients (n=1000) will also be retrospectively entered in the database in an anonymous way. For these patients, no specific study procedure is foreseen and the MICAT database will be only used as a platform (database of anonymous data collected during routine clinical practice).

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-07-01
• Study First Submitted QC: 2014-07-01
• Study First Posted: 2014-07-02
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-06
• Last Update Posted: 2024-10-08
• Primary Completion: 2028-09
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• clinical indication to coronary angiography

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Consecutive patients undergoing coronary angiography	observational only- no intervention	Consecutive patients undergoing coronary angiography at the University Medical Center Mainz - no inclusion criteria specified. The absorb substudy will include consecutive patients who received an Absorb scaffold based on clinical indication.

Primary Outcome Measures

Name	Time	Method
Major adverse cardiovascular events	baseline to 10 years	Incidence of major adverse events (death, death of cardiac cause, TLR - target lesion revascularization, MI)

Secondary Outcome Measures

Name	Time	Method
Individual endpoints	baseline to 10 years	Each individual endpoint of the MACE previously described
Other cardiovascular endpoints	baseline to 10 years	TVR - target vessel revascularization, re-hospitalization, change in medications.

Trial Locations

Locations (1)

University Medical Center Mainz - 2 Medizinische Klinik; 🇩🇪 Mainz, Germany