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

NCT02180178 | Recruiting

• 1 other identifier: MICAT
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Microvascular Dysfunction

Keywords

microvascular disease; coronary artery disease; Coronary artery disease, with or without microvascular dysfuntion

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular events

  Incidence of major adverse events (death, death of cardiac cause, TLR - target lesion revascularization, MI)

  baseline to 10 years

Secondary Outcomes (2)

• Individual endpoints

  baseline to 10 years

• Other cardiovascular endpoints

  baseline to 10 years

Study Arms (1)

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

Interventions

observational only- no intervention OTHER

Consecutive patients undergoing coronary angiography

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with clinical indication for coronary angiography.

You may qualify if:

• clinical indication to coronary angiography

You may not qualify if:

• none

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

University Medical Center Mainz - 2 Medizinische Klinik

Mainz, 55131, Germany

RECRUITING

Related Publications (2)

• 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.

  PMID: 29216999 DERIVED

• 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.

  PMID: 26916481 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum samples from patients with slow flow

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Tommaso Gori, PhD Dott Med e Chirurgia

  University Medical Center Mainz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tommaso Gori, PhD, Dott medicina e Chirurgia

CONTACT

+49 6131 172829; tommaso.gori@unimedizin-mainz.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 1, 2014
• First Posted: July 2, 2014
• Study Start: September 1, 2013
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

DE (1)