Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT05412732
Eligibility Criteria:
Inclusion Criteria:
* Patients who have suffered AMI or cardiorespiratory arrest after AMI, have been admitted to hospital within the first 24 hours of the event and are required to be admitted to any Critical Care Unit. In addition, one of the following criteria must be met:
1. Symptoms of cardiac ischaemia.
2. New ischaemic patterns in the ECG.
3. Development of pathological QW waves on the ECG.
4. Obvious suspicion or loss of myocardial viability or new abnormal motility regions in a pattern consistent with ischaemic pathology.
5. Intracoronary thrombus detected on angiography or autopsy. 2. They must be of legal age, have read the Patient Information Sheet (HIP) and have signed the Informed Consent (IC).
Depending on the group in which they are to be classified, patients must meet specific inclusion criteria:
Group A: Patients who have suffered MI (myocardial infarction), are in the CRITICAL UNIT and their DNAmit values are below 0.25-105 copies.
Group B: Patients who have suffered an MI, are in the CRITICAL UNIT and their mtDNA values are above 0.25-105 copies.
Exclusion Criteria:
Patients who meet any of the following criteria shall not be eligible for inclusion in the clinical trial:
1. Chronic inflammatory diseases
2. Transplantation of any organ (except cornea).
3. Patients receiving or who have received in the last 3 months anti-inflammatory, immunosuppressive or biological treatment targeting the immune system (TNF blockers, anakinra, rituximab, abatacept or tocilizumab), except NSAIDs and colchicine.
4. Patients with overt and/or severe immunocompromise
5. History of chronic kidney or liver disease (dialysis or creatinine clearance \< 30%).
6. Decompensated diabetes
7. Active tumour process. Patients considered to be in complete remission may be included in the study.
8. Major surgical intervention (in the 3 MONTHS PRIOR to inclusion in the study).
9. Pregnancy, childbirth or breastfeeding in the last 3 months.
10. Symptomatic patients with type IV heart failure (NYHA).
11. Life expectancy of less than 3 months.
12. Long-term urinary catheter or vascular catheter wearers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT05412732
Study Brief:
Protocol Section:
NCT05412732