Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02180178
Recruitment Status : Recruiting
First Posted : July 2, 2014
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Tommaso Gori, Johannes Gutenberg University Mainz

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
Coronary Artery Disease Microvascular Dysfunction 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).


Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Other
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

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



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Individual endpoints [ Time Frame: baseline to 10 years ]
    Each individual endpoint of the MACE previously described

  2. Other cardiovascular endpoints [ Time Frame: baseline to 10 years ]
    TVR - target vessel revascularization, re-hospitalization, change in medications.


Biospecimen Retention:   Samples Without DNA
serum samples from patients with slow flow


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with clinical indication for coronary angiography.
Criteria

Inclusion Criteria:

  • clinical indication to coronary angiography

Exclusion Criteria:

  • none

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Tommaso Gori, PhD, Dott medicina e Chirurgia +49 6131 172829 tommaso.gori@unimedizin-mainz.de

Locations
Layout table for location information
Germany
University Medical Center Mainz - 2 Medizinische Klinik Recruiting
Mainz, Germany, 55131
Contact: Tommaso Gori, PhD Dott Med Chir    +496131172829    tommaso.gori@unimedizin-mainz.de   
Principal Investigator: Tommaso Gori         
Sub-Investigator: Boris Schnorbus, Dr med         
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Investigators
Layout table for investigator information
Principal Investigator: Tommaso Gori, PhD Dott Med e Chirurgia University Medical Center Mainz

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Tommaso Gori, Prof., Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT02180178     History of Changes
Other Study ID Numbers: MICAT
First Posted: July 2, 2014    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Keywords provided by Tommaso Gori, Johannes Gutenberg University Mainz:
microvascular disease
coronary artery disease
Coronary artery disease, with or without microvascular dysfuntion
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases