MICAT: Mainz Intracoronary Database. The Coronary Slow-flow and Microvascular Diseases Registry
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Major adverse cardiovascular events [baseline to 10 years]
Incidence of major adverse events (death, death of cardiac cause, TLR - target lesion revascularization, MI)
Secondary Outcome Measures
- Individual endpoints [baseline to 10 years]
Each individual endpoint of the MACE previously described
- Other cardiovascular endpoints [baseline to 10 years]
TVR - target vessel revascularization, re-hospitalization, change in medications.
Eligibility Criteria
Criteria
Inclusion Criteria:
- clinical indication to coronary angiography
Exclusion Criteria:
- none
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Medical Center Mainz - 2 Medizinische Klinik | Mainz | Germany | 55131 |
Sponsors and Collaborators
- Johannes Gutenberg University Mainz
Investigators
- Principal Investigator: Tommaso Gori, PhD Dott Med e Chirurgia, University Medical Center Mainz
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MICAT