Study for the Validation of a New Biomarker to Determine Predisposition to Infections in Patients With Acute Myocardial Infarction.
NCT ID: NCT05412732
Last Updated: 2022-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2021-07-21
2023-07-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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group A low risk of infection
prospective biomedical research study
A prospective biomedical study, in which a comparison will be made of the outcome of a specific disease (in this case, AMI).
group B high risk of infection
prospective biomedical research study
A prospective biomedical study, in which a comparison will be made of the outcome of a specific disease (in this case, AMI).
Interventions
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prospective biomedical research study
A prospective biomedical study, in which a comparison will be made of the outcome of a specific disease (in this case, AMI).
Eligibility Criteria
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Inclusion Criteria
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).
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
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
18 Years
100 Years
ALL
No
Sponsors
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Crazy Science & Business S.L.
UNKNOWN
Instituto de Investigación Hospital Universitario La Paz
OTHER
Responsible Party
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Locations
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Hospital Universitario La Paz
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BIOMIN-001
Identifier Type: -
Identifier Source: org_study_id
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