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

NCT05781087 | Recruiting

• 2 other identifiers: 292740FS/CRTF/22/24342
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Artery Disease; ST Elevation Myocardial Infarction; Ischemic Heart Disease

Keywords

optical coherence tomography; non-culprit; magnetic resonance imaging; cardiac magnetic resonance; STEMI; magnetic resonance angiography; OCT

Outcome Measures

Primary Outcomes (1)

• Change in mean fibrous cap thickness measured by optical coherence tomography

  6 months

Secondary Outcomes (3)

• Change in mean lipid arc measured by optical coherence tomography

  6 months

• Presence of thin cap fibroatheroma measured by optical coherence tomography

  6 months

• Change in measures of shear stress made by optical coherence tomography and magnetic resonance angiography

  0 and 6 months

Other Outcomes (2)

• Non-culprit major adverse cardiac events

  6 months and 36 months

• Change in vessel stenosis measured by optical coherence tomography and magnetic resonance angiography

  0, 6 and 36 months

Study Arms (1)

Standard of care

Patients after ST-elevation myocardial infarction with non-culprit coronary artery disease.

Diagnostic Test: Optical coherence tomography and pressure wire assessment; Diagnostic Test: Cardiac magnetic resonance angiogram

Interventions

Optical coherence tomography and pressure wire assessment DIAGNOSTIC_TEST

Non-culprit coronary arteries

Also known as: OCT (Abbott), PressureWire X (Abbott)

Standard of care

Cardiac magnetic resonance angiogram DIAGNOSTIC_TEST

1.5T

Also known as: Cardiac MRI

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients after presentation with ST elevation myocardial infarction.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator
• King's College Hospital NHS Trust: collaborator

Study Sites (2)

St Thomas' Hospital

London, SE1 7EH, United Kingdom

RECRUITING

King's College Hospital

London, SE5 9RS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; ST Elevation Myocardial Infarction; Myocardial Ischemia

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Divaka Perera, MD

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Li Kam Wa, MBBS

CONTACT

02071887188; mlikamwa@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 23, 2023
• Study Start: April 25, 2023
• Primary Completion: October 1, 2025
• Study Completion (Estimated): April 1, 2028
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)