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

Mainzer IntraCoronAry daTabase (MICAT). Das Coronary Slow Flow- Syndrom Und Koronare Mikrozirkulationsstörungen- Register.

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Microvascular Dysfunction
• Intervention / Treatment: Other: observational only- no intervention

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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Tommaso Gori, PhD, Dott medicina e Chirurgia; Phone Number: +49 6131 172829; Email: tommaso.gori@unimedizin-mainz.de

Study Locations

• Germany
  • Mainz, Germany, 55131
    • Recruiting
    • University Medical Center Mainz - 2 Medizinische Klinik
    • Contact: Tommaso Gori, PhD Dott Med Chir; Phone Number: +496131172829; Email: tommaso.gori@unimedizin-mainz.de
    • Principal Investigator: Tommaso Gori
    • Sub-Investigator: Boris Schnorbus, Dr med

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with clinical indication for coronary angiography.

Description

Inclusion Criteria:

• clinical indication to coronary angiography

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: observational only- no intervention

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz
• Investigators: Principal Investigator: Tommaso Gori, PhD Dott Med e Chirurgia, University Medical Center Mainz

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: July 1, 2014
• First Submitted That Met QC Criteria: July 1, 2014
• First Posted (Estimate): July 2, 2014

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: coronary artery disease; microvascular disease; Coronary artery disease, with or without microvascular dysfuntion
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: MICAT