Mainz Intracoronary Database. The Coronary Slow-flow and Microvascular Diseases Registery (MICAT)
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|ClinicalTrials.gov Identifier: NCT02180178|
Recruitment Status : Recruiting
First Posted : July 2, 2014
Last Update Posted : March 22, 2019
|Condition or disease||Intervention/treatment|
|Coronary Artery Disease Microvascular Dysfunction||Other: observational only- no intervention|
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 [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||Mainzer IntraCoronAry daTabase (MICAT). Das Coronary Slow Flow- Syndrom Und Koronare Mikrozirkulationsstörungen- Register.|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
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
- Major adverse cardiovascular events [ Time Frame: baseline to 10 years ]Incidence of major adverse events (death, death of cardiac cause, TLR - target lesion revascularization, MI)
- Individual endpoints [ Time Frame: baseline to 10 years ]Each individual endpoint of the MACE previously described
- Other cardiovascular endpoints [ Time Frame: baseline to 10 years ]TVR - target vessel revascularization, re-hospitalization, change in medications.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02180178
|Contact: Tommaso Gori, PhD, Dott medicina e Chirurgia||+49 6131 email@example.com|
|University Medical Center Mainz - 2 Medizinische Klinik||Recruiting|
|Mainz, Germany, 55131|
|Contact: Tommaso Gori, PhD Dott Med Chir +496131172829 firstname.lastname@example.org|
|Principal Investigator: Tommaso Gori|
|Sub-Investigator: Boris Schnorbus, Dr med|
|Principal Investigator:||Tommaso Gori, PhD Dott Med e Chirurgia||University Medical Center Mainz|