Predicting the Risk of Non-culprit Coronary Artery Disease After a Heart Attack (OCT-RISK)

September 24, 2024 updated by: Guy's and St Thomas' NHS Foundation Trust

Optical Coherence Tomography With Magnetic Resonance Angiography to Assess STEMI Non-culprit Risk

Heart attacks caused by the complete blockage of a heart artery are treated by opening it with a stent. However, most people will also have 'non-culprit' narrowings found in their other arteries at this time.

Although in general people do better if these non-culprit narrowings are also treated with stents if they look severe, this process has problems. This is because narrowings that look severe may be stable and not cause any trouble. For these people a stent is a wasted procedure and unnecessary risk. On the other hand, narrowings that are currently left alone because they appear mild, may progress and cause a heart attack.

Participants who have had a heart attack will have a scan from inside the heart arteries during an angiogram (optical coherence tomography, OCT) and a magnetic resonance angiogram (MRA).

If the investigators can show that it is possible to accurately predict which non-culprit narrowings are going to progress and which are going to stabilise, medical professionals may be able to better target their treatments after a heart attack.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Matthew Li Kam Wa, MBBS
  • Phone Number: 02071887188
  • Email: mlikamwa@nhs.net

Study Locations

  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • Recruiting
        • King's College Hospital
        • Contact:
        • Principal Investigator:
          • Ian Webb, PhD
      • London, United Kingdom, SE1 7EH
        • Recruiting
        • St Thomas' Hospital
        • Contact:
        • Principal Investigator:
          • Divaka Perera, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients after presentation with ST elevation myocardial infarction.

Description

Inclusion Criteria:

  • Successful primary percutaneous coronary intervention (PCI) within the previous week with no major complications at the index procedure
  • Bystander disease in a non-culprit vessel planned for clinically indicated staged angiography +/- PCI
  • Able to provide written informed consent.

Exclusion Criteria:

  • Cardiogenic shock requiring intubation, inotropes or a mechanical support device
  • Creatinine clearance <30ml/min
  • Prior coronary artery bypass grafting
  • Life expectancy less than 3 years
  • Pregnancy.
  • Target lesion in the left main coronary artery
  • Severe calcification or tortuosity that would threaten safe placement of a pressure wire or OCT catheter
  • Chronic total occlusion of a major epicardial vessel.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Standard of care
Patients after ST-elevation myocardial infarction with non-culprit coronary artery disease.
Diagnostic test: Optical coherence tomography and pressure wire assessment
Non-culprit coronary arteries
Other Names:
  • OCT (Abbott)
  • PressureWire X (Abbott)
Diagnostic test: Cardiac magnetic resonance angiogram
1.5T
Other Names:
  • Cardiac MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in mean fibrous cap thickness measured by optical coherence tomography
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mean lipid arc measured by optical coherence tomography
Time Frame: 6 months
6 months
Presence of thin cap fibroatheroma measured by optical coherence tomography
Time Frame: 6 months
Plaque with lipid arc >90° and fibrous cap thickness ≤65µm
6 months
Change in measures of shear stress made by optical coherence tomography and magnetic resonance angiography
Time Frame: 0 and 6 months
Comparison between non-invasive and invasively derived measures
0 and 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-culprit major adverse cardiac events
Time Frame: 6 months and 36 months
Death, myocardial infarction, ischaemia driven revascularisation
6 months and 36 months
Change in vessel stenosis measured by optical coherence tomography and magnetic resonance angiography
Time Frame: 0, 6 and 36 months
Comparison between non-invasive and invasively derived measures
0, 6 and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborators

King's College London
King's College Hospital NHS Trust

Investigators

  • Principal Investigator: Divaka Perera, MD, King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

March 9, 2023

First Submitted That Met QC Criteria

March 21, 2023

First Posted (Actual)

March 23, 2023

Study Record Updates

Last Update Posted (Actual)

September 25, 2024

Last Update Submitted That Met QC Criteria

September 24, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 292740
  • FS/CRTF/22/24342 (Other Grant/Funding Number: British Heart Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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