Understanding the risks of non-culprit coronary arteries in heart attack patients
Anatomical, Physiological and Inflammatory Characterization of the Non-Culprit Vessels in Patients Undergoing Primary PCI for ST-Elevation Myocardial Infarction in the Presence of Multivessel Disease Toward a Personalised Approach to Complete Revascularisation After Primary PCI
This study is trying to understand the risks of untreated arteries in heart attack patients to see if fixing them can improve their health after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 320 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital Southampton NHS Foundation Trust Academic / other |
| Locations | 3 sites (Bournemouth, Dorset and 2 other locations) |
| Trial ID | NCT06506448 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize the risk associated with non-culprit coronary arteries in patients who have undergone primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI). It will utilize CT coronary angiography to assess the condition of these arteries and investigate the variability in susceptibility to ischemic events among individuals. The study seeks to provide mechanistic insights into how complete revascularization of chronic bystander disease may influence patient outcomes. By analyzing data from patients with multivessel coronary artery disease, the researchers hope to clarify the necessity and benefits of treating non-culprit lesions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 85 who present with acute STEMI and have significant stenosis in non-infarct related arteries.
Not a fit: Patients with severe comorbidities, such as cardiogenic shock or those requiring immediate surgical intervention, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for patients with STEMI and multivessel disease, potentially improving outcomes and resource utilization.
How similar studies have performed: Previous studies have shown some success with complete revascularization approaches, but this study aims to provide new mechanistic insights that have not been fully explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Ability to provide written informed consent (post PPCI)
2. Age 18 years to 85 years
3. Presentation of acute STEMI within 12 hours of symptom on-set
4. Culprit artery PPCI
5. Coronary stenosis of \> 50% diameter stenosis by visual estimation in NIRA with a minimum diameter of 2.5mm
Exclusion Criteria:
1. Cardiogenic shock
2. Decompensated heart failure requiring intubation, inotropes, or intra-aortic balloon counter pulsation
3. Refractory ventricular arrhythmia
4. Previous coronary artery bypass surgery (CABG)
5. Stent thrombosis and in stent restenosis
6. An intention before inclusion into the study to revascularize a non-culprit lesion
7. Active malignancy or inflammatory disorders such as rheumatoid arthritis or inflammatory bowel disease
8. Severe valvular heart disease requiring surgery
9. Planned surgical revascularisation
10. Active participation in another study/trial
11. \< 12 months life expectancy
12. Contraindication to CTCA
* Presence of internal defibrillator
* Known allergy to iodinated contrast
* Pregnancy
* Contraindication to intravenous beta blockade
* Contraindication to acute sublingual nitrate administration
* Mechanical prosthetic heart valve
* Advanced renal impairment (creatinine \>200)
* Significant valve disease (sever aortic stenosis or regurgitation; severe mitral regurgitation)
Angiographic exclusion criteria
1. NIRA stenosis of 50% or more in the left main stem or the ostia of both the left anterior descending and circumflex arteries
2. \< TIMI (thrombolysis in myocardial infarction) flow grade 3 in the NIRA,
3. Evidence of thrombus in the NIRA.
Where this trial is running
Bournemouth, Dorset and 2 other locations
- University Hospitals Dorset NHS Foundation Trust — Bournemouth, Dorset, United Kingdom (Recruiting)
- University Hospital Southampton NHS Foundation Trust — Southampton, Hampshire, United Kingdom (Recruiting)
- Royal Stoke University Hospital — Stoke-on-Trent, Staffordshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Nick Curzen, PhD — University Hospital Southampton NHS Foundation Trust
- Study coordinator: Zoe Nicholas
- Email: zoe.nicholas@uhs.nhs.uk
- Phone: 02381208538
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.