Risk Characterization of Non-culprit Vessels in Patients Undergoing Primary PCI for ST-elevation MI in Multivessel Disease

NCT06506448 | Recruiting

• 1 other identifier: RHMCAR0647
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 3

Brief Summary

Most heart attacks occur because a clot forms in a coronary artery blocking blood flow. Without blood heart muscle dies. Untreated, clots can cause a specific type of heart attack -ST-elevation myocardial infarction (STEMI). STEMI patients are treated immediately by finding the blocked artery ("culprit" lesion) using a dye injected into the coronary arteries and then by unblocking the artery using balloons and stents. This procedure - primary angioplasty - is offered 24/7 and limits the size of heart attacks and saves lives. Cardiologists know how to treat STEMI patients but it's less clear what to do about narrowings in other coronary arteries ("bystander" disease). This is important - if they're left alone some bystander lesions can cause future events including heart attacks or angina. Recent trials compared stenting ALL the bystander narrowings after primary angioplasty, with stenting none and showed some benefit from stenting all of them ("complete revascularisation"). However, complete revascularisation carries extra risk, putting patients through more complicated procedures and using up resource. A blanket strategy of complete revascularisation of ALL bystander narrowings in ALL STEMI patients is unlikely to be the correct answer as only a small minority of these patients have further events. In PICNIC the investigators want to identify bystander narrowings most likely to cause a future event, and those unlikely to do so. The study can then test the hypothesis that only the high-risk bystander narrowings need stenting, and the others can be treated with tablets only. Investigators will study patients using specialised imaging techniques from coronary artery CT scans and levels of inflammation to see which narrowings cause future events and which do not. If this can be done, a case can be made to test complete revascularisation only in bystander narrowings that look high risk.

Conditions

ST Elevation Myocardial Infarction

Keywords

Primary percutaneous coronary intervention; Infarct related artery; Non-infarct related artery; Computerised Tomography Coronary Angiography CTCA; Fractional Flow Reserve from CT (FFRct); Fat Attenuation Index (FAI); Inflammation

Outcome Measures

Primary Outcomes (1)

• Correlation between major adverse cardiac & cerebrovascular events (MACCE) and CTCA-derived anatomical, physiological, plaque & inflammatory characteristics and serum inflammatory markers at 2 years

  Correlation between: 1. major adverse cardiac \& cerebrovascular events (MACCE) defined as the composite of all-cause mortality, cardiovascular death, cardiac arrest, acute coronary syndrome (unstable angina, NSTEMI, or STEMI), additional revascularization by CABG or PCI, rehospitalisation for angina, heart failure, stroke, ventricular or atrial fibrillation or tachyarrhythmia at 2 years \&: 2. Anatomical \& physiological characteristics of coronary vessels/lesions in the NIRA(s) as assessed by CTCA parameters (FFRCT + FAI + plaque characteristics)

  2 years

Secondary Outcomes (4)

• Correlation between major adverse cardiac & cerebrovascular events (MACCE) and components of CTCA-derived anatomical, physiological, plaque & inflammatory characteristics and serum inflammatory markers at 1 year

  1 year

• Correlation between anatomical, physiological & serum inflammatory markers and future adverse events at 3 years

  3 years

• Development of a risk score to predict clinical events based upon individual-, vessel- & lesion-specific factors

  1 year

• Development of a risk score to predict clinical events based upon individual-, vessel- & lesion-specific factors

  3 years

Study Arms (1)

STEMI patients with multivessel disease

320 patients undergoing primary angioplasty for ST-elevation myocardial infarction (STEMI) who have bystander disease in a main coronary artery with at least one stenosis of 50% or more

Diagnostic Test: CT Coronary Angiography

Interventions

CT Coronary Angiography DIAGNOSTIC_TEST

CTCA for anatomical, physiological, plaque composition and inflammatory assessment of coronary arteries

Also known as: FFRCT and plaque analysis (HeartFlow) and Fat Attenuation Index (Caristo)

STEMI patients with multivessel disease

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting with ST elevation myocardial infarction who are found to have significant stenoses in the non-infarct related artery(s) defined as coronary stenosis \>50% by visual estimation

You may qualify if:

• Ability to provide written informed consent (post PPCI)
• Age 18 years to 85 years
• Presentation of acute STEMI within 12 hours of symptom on-set
• Culprit artery PPCI
• Coronary stenosis of \> 50% diameter stenosis by visual estimation in NIRA with a minimum diameter of 2.5mm

You may not qualify if:

• Cardiogenic shock
• Decompensated heart failure requiring intubation, inotropes, or intra-aortic balloon counter pulsation
• Refractory ventricular arrhythmia
• Previous coronary artery bypass surgery (CABG)
• Stent thrombosis and in stent restenosis
• Active malignancy or inflammatory disorders such as rheumatoid arthritis or inflammatory bowel disease
• Severe valvular heart disease requiring surgery
• Planned surgical revascularisation
• Active participation in another study/trial
• \< 12 months life expectancy
• Contraindication to CTCA
• Presence of internal defibrillator
• Known allergy to iodinated contrast
• Pregnancy
• Contraindication to intravenous beta blockade

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• Boston Scientific Corporation: collaborator
• HeartFlow, Inc.: collaborator
• Wessex Heartbeat: collaborator
• Caristo: collaborator

Study Sites (3)

University Hospitals Dorset NHS Foundation Trust

Bournemouth, Dorset, BH15 2JB, United Kingdom

RECRUITING

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

RECRUITING

Royal Stoke University Hospital

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Single blood sample taken from participants at baseline

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Inflammation

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Nick Curzen, PhD

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoe Nicholas

CONTACT

02381208538; zoe.nicholas@uhs.nhs.uk

Study Design

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

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: July 17, 2024
• Study Start: January 20, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): January 1, 2029
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)