Predicting the Risk of Non-culprit Coronary Artery Disease After a Heart Attack (NCT05781087) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Predicting the Risk of Non-culprit Coronary Artery Disease After a Heart Attack
United Kingdom90 participantsStarted 2023-04-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying non-culprit coronary artery disease after a heart attack using optical coherence tomography — could you explain what 'non-culprit' vessels are and why monitoring them after my heart attack might be important for my care?
2Since this trial is 'active but not recruiting,' does that mean I've missed the window to participate, and are there similar ongoing studies looking at plaque vulnerability in coronary arteries that I might still be eligible for?
3The trial is measuring changes in fibrous cap thickness using optical coherence tomography — is that imaging technology something that would be used in my regular care anyway, or would participating in a study like this involve extra procedures that carry additional risks?
4This study appears to be observational or predictive in nature rather than testing a new treatment — does that mean it wouldn't change my actual treatment plan, and if so, how would the findings from something like this eventually benefit me or future patients?
5Given that this research is focused on predicting risk after a heart attack, what are the standard-of-care approaches you would recommend for managing my non-culprit coronary artery disease right now, while this kind of research is still ongoing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in mean fibrous cap thickness measured by optical coherence tomography