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

NCT ID: NCT02180178

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2028-09-30

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).

Conditions

Coronary Artery Disease; Microvascular Dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Consecutive patients undergoing coronary angiography

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.

observational only- no intervention

Intervention Type: OTHER

Interventions

observational only- no intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• clinical indication to coronary angiography

Exclusion Criteria

• none

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johannes Gutenberg University Mainz

OTHER

Sponsor Role: lead

Responsible Party

Tommaso Gori

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tommaso Gori, PhD Dott Med e Chirurgia

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Mainz

Locations

University Medical Center Mainz - 2 Medizinische Klinik

Mainz, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Tommaso Gori, PhD, Dott medicina e Chirurgia

Role: CONTACT

tommaso.gori@unimedizin-mainz.de

+49 6131 172829

Facility Contacts

Tommaso Gori, PhD Dott Med Chir

Role: primary

tommaso.gori@unimedizin-mainz.de

+496131172829

References

Gori T, Weissner M, Gonner S, Wendling F, Ullrich H, Ellis S, Anadol R, Polimeni A, Munzel T. Characteristics, Predictors, and Mechanisms of Thrombosis in Coronary Bioresorbable Scaffolds: Differences Between Early and Late Events. JACC Cardiovasc Interv. 2017 Dec 11;10(23):2363-2371. doi: 10.1016/j.jcin.2017.08.020.

Reference Type: DERIVED

PMID: 29216999 (View on PubMed)

Puricel S, Cuculi F, Weissner M, Schmermund A, Jamshidi P, Nyffenegger T, Binder H, Eggebrecht H, Munzel T, Cook S, Gori T. Bioresorbable Coronary Scaffold Thrombosis: Multicenter Comprehensive Analysis of Clinical Presentation, Mechanisms, and Predictors. J Am Coll Cardiol. 2016 Mar 1;67(8):921-931. doi: 10.1016/j.jacc.2015.12.019.

Reference Type: DERIVED

PMID: 26916481 (View on PubMed)

Other Identifiers

MICAT

Identifier Type: -

Identifier Source: org_study_id