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NCT Number: NCT05781087

Predicting the Risk of Non-culprit Coronary Artery Disease After a Heart Attack

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Bournemouth Hospital, Bournemouth, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Optical coherence tomography and pressure wire assessment

Diagnostic Test

Non-culprit coronary arteries

Other names: OCT (Abbott), PressureWire X (Abbott)

Cardiac magnetic resonance angiogram

Diagnostic Test

1.5T

Other names: Cardiac MRI

Primary outcomes

  1. Change in mean fibrous cap thickness measured by optical coherence tomography

    Time frame: 6 months

Secondary outcomes

  1. Change in mean lipid arc measured by optical coherence tomography

    Time frame: 6 months

  2. Presence of thin cap fibroatheroma measured by optical coherence tomography

    Time frame: 6 months

    Plaque with lipid arc >90° and fibrous cap thickness ≤65µm

  3. 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

Other outcomes

  1. Non-culprit major adverse cardiac events

    Time frame: 6 months and 36 months

    Death, myocardial infarction, ischaemia driven revascularisation

  2. 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

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Collaborators

  • Imperial College London
  • King's College London

Registry information

Official study title

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

Acronym: OCT-RISK

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Mar 23, 2023
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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