NCT06302777

Brief 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 progression.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
65mo left

Started Sep 2023

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Sep 2023Sep 2031

Study Start

First participant enrolled

September 26, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2028

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2031

Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

5 years

First QC Date

March 4, 2024

Last Update Submit

March 4, 2024

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiovascular Events (MACE)

    after 2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ACS or SAP patients

You may qualify if:

  • patients undergoing pre-intervention optical coherence tomography imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Frankfurt University Hospital

Frankfurt am Main, Hesse, 60590, Germany

RECRUITING

Frankfurt University Hospital

Frankfurt, Germany

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Lena Seegers, MD

CONTACT

+4963016666lena.seegers@herz-frankfurt.de

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 12, 2024

Study Start

September 26, 2023

Primary Completion (Estimated)

September 26, 2028

Study Completion (Estimated)

September 26, 2031

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations

DE(2)