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

Recruiting

• Conditions: Ischemic Heart Disease; ST Elevation Myocardial Infarction; Coronary Artery Disease
• Interventions: Diagnostic Test: Optical coherence tomography and pressure wire assessment; Diagnostic Test: Cardiac magnetic resonance angiogram

• Registration Number: NCT05781087
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-09
• Study First Submitted QC: 2023-03-21
• Study First Posted: 2023-03-23
• Study Start: 2023-04-25
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-13
• Primary Completion: 2024-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard of care	Optical coherence tomography and pressure wire assessment	Patients after ST-elevation myocardial infarction with non-culprit coronary artery disease.
Standard of care	Cardiac magnetic resonance angiogram	Patients after ST-elevation myocardial infarction with non-culprit coronary artery disease.

Primary Outcome Measures

Name	Time	Method
Change in mean fibrous cap thickness measured by optical coherence tomography	6 months

Secondary Outcome Measures

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

Trial Locations

Locations (2)

King's College Hospital; 🇬🇧 London, United Kingdom

St Thomas' Hospital; 🇬🇧 London, United Kingdom