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RecruitingNCT02180178MICATUpdated Oct 8, 2024

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

An observational study in Coronary Artery Disease and Microvascular Dysfunction, sponsored by Johannes Gutenberg University Mainz. Recruiting at 1 site in Germany. Per ClinicalTrials.gov, last updated 2024-10-08.

Sponsored by Johannes Gutenberg University Mainz · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
1,000
Sex
All
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Study 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 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).

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Conditions studied

  • Coronary Artery Disease
  • Microvascular Dysfunction

Keywords

  • microvascular disease
  • coronary artery disease
  • Coronary artery disease, with or without microvascular dysfuntion
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In context

Coronary Artery Disease

5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 336 across 1,946 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Johannes Gutenberg University Mainz is the lead sponsor of 153 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with clinical indication for coronary angiography.

Inclusion criteria

  • clinical indication to coronary angiography

Exclusion criteria

Exclusion Criteria:

  • none
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
1,000 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

Interventions

  • Otherobservational only- no intervention
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What researchers measure

Primary outcomes

  1. Major adverse cardiovascular events

    Incidence of major adverse events (death, death of cardiac cause, TLR - target lesion revascularization, MI)

    Time frame: baseline to 10 years

Secondary outcomes

  1. Individual endpoints

    Each individual endpoint of the MACE previously described

    Time frame: baseline to 10 years

  2. Other cardiovascular endpoints

    TVR - target vessel revascularization, re-hospitalization, change in medications.

    Time frame: baseline to 10 years

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Study locations

1 of 1 sites recruiting
  • University Medical Center Mainz - 2 Medizinische Klinik
    Mainz, 55131, Germany
    • Tommaso Gori, PhD Dott Med Chir · Contact · tommaso.gori@unimedizin-mainz.de · +496131172829
    • Tommaso Gori · Principal investigator
    • Boris Schnorbus, Dr med · Sub investigator
    Recruiting
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References and documents

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 29216999 ↗
  • Puricel 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02180178
Lead sponsor
Johannes Gutenberg University Mainz
Responsible party
Tommaso Gori (Prof., Johannes Gutenberg University Mainz) — Principal investigator
First posted
Jul 2, 2014
Start date
Sep 2013
Primary completion
Sep 2028 (estimated)
Completion
Sep 2028 (estimated)
Last update
Oct 8, 2024

Study contacts

Tommaso Gori, PhD, Dott medicina e Chirurgia
Contact
tommaso.gori@unimedizin-mainz.de
+49 6131 172829
Tommaso Gori, PhD Dott Med e Chirurgia
principal investigator · University Medical Center Mainz

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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