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

Coronary Artery Disease Clinical Trial

— MICAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02180178
• Other study ID #: MICAT
• Status: Recruiting
• Start date: September 2013
• Est. completion date: September 2023

Study information

• Verified date: March 2022
• Source: Johannes Gutenberg University Mainz
• Contact: Tommaso Gori, PhD, Dott medicina e Chirurgia
• Phone: +49 6131 172829
• Email: tommaso.gori[@]unimedizin-mainz.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• clinical indication to coronary angiography

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Microvascular Dysfunction
• Myocardial Ischemia

Intervention

Other:
• observational only- no intervention

Locations

Country	Name	City	State
Germany	University Medical Center Mainz - 2 Medizinische Klinik	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiovascular events	Incidence of major adverse events (death, death of cardiac cause, TLR - target lesion revascularization, MI)	baseline to 10 years
Secondary	Individual endpoints	Each individual endpoint of the MACE previously described	baseline to 10 years
Secondary	Other cardiovascular endpoints	TVR - target vessel revascularization, re-hospitalization, change in medications.	baseline to 10 years