Factor XIII and Other Biomarkers in ST Segment Elevation Myocardial Infarction (NCT03523624) | Clinical Trial Compass
CompletedNot Applicable
Factor XIII and Other Biomarkers in ST Segment Elevation Myocardial Infarction
Italy35 participantsStarted 2015-11-01
Plain-language summary
In medical practice, a combination of clinical exam, electrocardiograms, circulating biomarkers, and imaging is used to gain insights on the prognosis after myocardial infarction. Novel molecular non-invasive tools are needed that help clinicians overcome the adverse events of post-myocardial infarction remodelling and thereby achieve improved therapy for its prevention.
Coagulation factor XIII (FXIII) decay has been linked to major adverse cardiac events (MACE) in patients with acute coronary syndromes. Given the correlation between both intramyocardial haemorrhage and microvascular damage with acute phase complications in ST-elevation myocardial infarction, we hypothesise that excessive FXIII decay within the first week may predict acute phase outcomes in these patients. If this holds true, FXIII determination could be used as diagnostic and prognostic tool.
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 with the clinical presentation of ST-elevation myocardial infarction within 12 h of symptom onset and with persistent ST-segment elevation or new or presumed new left bundle branch block and undergoing primary percutaneous coronary intervention (PCI)
Exclusion Criteria:
* patients with late presentation ST-elevation myocardial infarction (beyond the first 12h after onset of symptoms) or ineligible for mechanical reperfusion therapy
* contraindications to cardiac magnetic resonance
* pregnancy
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.
What they're measuring
1
FXIII decay correlation with intramyocardial haemorrhage/microvascular damage