Clinical trial NCT05781087: Predicting the Risk of Non-culprit Coronary Artery Disease After a Heart Attack
Official title: Optical Coherence Tomography With Magnetic Resonance Angiography to Assess STEMI Non-culprit Risk
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: King's College London
name: King's College Hospital NHS Trust
First posted: 2023-03-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after presentation with ST elevation myocardial infarction.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in mean fibrous cap thickness measured by optical coherence tomography
timeFrame: 6 months
Secondary outcomes:
measure: Change in mean lipid arc measured by optical coherence tomography
timeFrame: 6 months
measure: Presence of thin cap fibroatheroma measured by optical coherence tomography
timeFrame: 6 months
measure: Change in measures of shear stress made by optical coherence tomography and magnetic resonance angiography
timeFrame: 0 and 6 months
Other outcomes:
measure: Non-culprit major adverse cardiac events
timeFrame: 6 months and 36 months
measure: Change in vessel stenosis measured by optical coherence tomography and magnetic resonance angiography
timeFrame: 0, 6 and 36 months
Locations:
city: London
country: United Kingdom
facility: St Thomas' Hospital
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
affiliation: King's College London
name: Divaka Perera, MD
role: PRINCIPAL_INVESTIGATOR
References: