Coronary Artery DiseaseMAIN-IMAGENCT06302777
MAIN-IMAGE Registry
An observational study of Coronary Artery Disease, run by Goethe University at 2 sites in Germany.
Trial summary
All comers registry with patients with chronic coronary syndrome or acute coronary syndrome who underwent intracoronary imaging during cardiac catherization. The aim is to identify plaque characteristics on OCT or IVUS that are associated with adverse cardiac events including myocardial infarction and atherosclerotic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 500 participants
- Where
- 2 sitesGermany
- Study dates
- 26 Sep 2023to 26 Sep 2031
- How long will I take part?
- 3 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ACS or SAP patients
Who may be able to join
- patients undergoing pre-intervention optical coherence tomography imaging
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Frankfurt University Hospital
Frankfurt
Lena Seegers
- Recruiting
Frankfurt University Hospital
Frankfurt am Main, Hesse, 60590
Lena Seegers, +496963016666
About this study
Official title: Multifactorial Analysis of Coronary Artery Plaques Using INtracoronary IMAGing for Exploration of Atherosclerotic Determinants and Progression - the MAIN-IMAGE Registry
All comers registry with patients with chronic coronary syndrome or acute coronary syndrome who underwent intracoronary imaging during cardiac catherization. The aim is to identify plaque characteristics on OCT or IVUS that are associated with adverse cardiac events including myocardial infarction and atherosclerotic progression.
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular Events (MACE)
Measured: after 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start26 Sep 2023
- Primary completion26 Sep 2028 (estimated)
- Study completion26 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Lena Marie Seegers, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302777
- Sponsor's protocol ID
- 2023-1184
- Acronym
- MAIN-IMAGE
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifactorial Analysis of Coronary Artery Plaques Using INtracoronary IMAGing for Exploration of Atherosclerotic Determinants and Progression - the MAIN-IMAGE Registry
- ClinicalTrials.gov ID
- NCT06302777
- Acronym / sponsor ID
- MAIN-IMAGE / 2023-1184
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 26 Sep 2028 (estimated)
- Study completion
- 26 Sep 2031 (estimated)
- First posted
- 12 Mar 2024 (actual)
- 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.
All comers registry with patients with chronic coronary syndrome or acute coronary syndrome who underwent intracoronary imaging during cardiac catherization. The aim is to identify plaque characteristics on OCT or IVUS that are associated with adverse cardiac events including myocardial infarction and atherosclerotic progression.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ACS or SAP patients
Key inclusion criteria (1 listed)
- patients undergoing pre-intervention optical coherence tomography imaging
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major adverse cardiovascular Events (MACE)
Time frame: after 2 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 12 Mar 2024.
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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.
2 sites 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, run by Goethe University at 2 sites 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 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Lena Seegers, MD (+4963016666, lena.seegers@herz-frankfurt.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 (MACE) (time frame: after 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2024.