Coronary Artery DiseaseMICATNCT02180178
Mainz Intracoronary Database. The Coronary Slow-flow and Microvascular Diseases Registry
An observational study of Coronary Artery Disease and Microvascular Dysfunction, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease, Microvascular Dysfunction
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2013to Sep 2028
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with clinical indication for coronary angiography.
Who may be able to join
- clinical indication to coronary angiography
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Mainz - 2 Medizinische Klinik
Mainz, 55131
Tommaso Gori, PhD Dott Med Chir, +496131172829, tommaso.gori@unimedizin-mainz.de
Tommaso Gori
About this study
Official title: Mainzer IntraCoronAry daTabase (MICAT). Das Coronary Slow Flow- Syndrom Und Koronare Mikrozirkulationsstörungen- Register.
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.
Read the 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).
- Conditions
- Coronary Artery Disease, Microvascular Dysfunction
- Being tested
- observational only- no intervention
- Keywords
- microvascular disease, coronary artery disease, Coronary artery disease, with or without microvascular dysfuntion
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational only- no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: observational only- no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events
Incidence of major adverse events (death, death of cardiac cause, TLR - target lesion revascularization, MI)
Measured: baseline to 10 years
Secondary outcomes (2)
Individual endpoints
Each individual endpoint of the MACE previously described
Measured: baseline to 10 years
Other cardiovascular endpoints
TVR - target vessel revascularization, re-hospitalization, change in medications.
Measured: baseline to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startSep 2013
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tommaso Gori, Johannes Gutenberg University Mainz
- Investigators
- Tommaso Gori, PhD Dott Med e Chirurgia, Principal investigator, University Medical Center Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180178
- Sponsor's protocol ID
- MICAT
- Acronym
- MICAT
- Status last verified
- Oct 2024
- First submitted
- 1 Jul 2014
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29216999Puricel 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.
PubMed 26916481
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mainzer IntraCoronAry daTabase (MICAT). Das Coronary Slow Flow- Syndrom Und Koronare Mikrozirkulationsstörungen- Register.
- ClinicalTrials.gov ID
- NCT02180178
- Acronym / sponsor ID
- MICAT / MICAT
- Conditions
- Coronary Artery Disease, Microvascular Dysfunction
- Keywords
- microvascular disease, coronary artery disease, Coronary artery disease, with or without microvascular dysfuntion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 2 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consecutive patients undergoing coronary angiography | – | Other: observational only- no interventionConsecutive 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with clinical indication for coronary angiography.
Key inclusion criteria (1 listed)
- clinical indication to coronary angiography
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational only- no intervention | Other | Consecutive patients undergoing coronary angiography |
Primary outcome
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)
2 secondary outcomes
Individual endpoints
Time frame: baseline to 10 years
Other cardiovascular endpoints
Time frame: baseline to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Derived from this study: PubMed 29216999Gori 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.
- Derived from this study: PubMed 26916481Puricel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tommaso Gori, PhD Dott Med e Chirurgia principal investigator
University Medical Center Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Microvascular Dysfunction, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tommaso Gori, PhD, Dott medicina e Chirurgia (+49 6131 172829, tommaso.gori@unimedizin-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (time frame: baseline to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02180178, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.