Systemic, Pancoronary and Local Coronary Vulnerability (NCT03606330) | Clinical Trial Compass
CompletedNot Applicable
Systemic, Pancoronary and Local Coronary Vulnerability
Romania100 participantsStarted 2018-10-22
Plain-language summary
• The aim of the VIP study is to investigate the impact of vulnerability markers (inflammatory serum biomarkers for systemic vulnerability, coronary shear stress and vulnerability mapping for pancoronary vulnerability, and imaging-based plaque features for systemic vulnerability) on the rate of major adverse cardiovascular events caused by progression of the non-culprit lesion in patients with acute ST or non-ST segment elevation myocardial infarction who undergo revascularization of the culprit lesion during the acute event. Furthermore, the study will evaluate the rate of progression of non-culprit lesions towards a higher degree of vulnerability, based on coronary computed tomography angiographic assessment at 1 year after enrollment.
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:
* Patients aged over 18 years old that have signed the written informed consent;
* Patients with ST and non-ST segment elevation myocardial infarction (as stated in the Third Universal Definition of Myocardial Infarction) at 30 days prior to randomization;
Exclusion Criteria:
* unwillingness or incapacity to provide informed consent (and if consent of legal guardian or family is not available);
* acute myocardial infarction at the moment of randomization (as these patients are referred to the hospital for emergency invasive coronary angiography and revascularization)
* conditions that present an estimated life expectancy of under 5 years;
* acute renal failure or terminal stage chronic kidney disease;
* pregnancy or lactation and women of reproductive age who are not using any contraceptive method;
* allergy and history of allergic reactions to iodine contrast media;
* active malignancy or malignancy within the last 1 year prior to enrollment;
* patients who, in the opinion of the investigators are not compliant and will not present for study visits.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.