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

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-21

Study Completion Date

2023-07-21

Brief Summary

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Prospective biomedical research study

Detailed Description

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The aim is to validate a new biomarker, based on the levels of DNAmit present in blood, to assess the predisposition of an individual to suffer an infection. To validate this hypothesis, the DNAmit levels of patients with myocardial infarction will be analysed and their relationship with the probability of these patients developing an infectious process or not.

Conditions

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Infections in Acute Myocardial Infarction Patients

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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group A low risk of infection

prospective biomedical research study

Intervention Type OTHER

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

Intervention Type OTHER

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).

Intervention Type OTHER

Eligibility Criteria

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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).


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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Crazy Science & Business S.L.

UNKNOWN

Sponsor Role collaborator

Instituto de Investigación Hospital Universitario La Paz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Universitario La Paz

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Miguel Ángel Llamas Matías

Role: CONTACT

+034 924 951 112

Beatriz Salvador Esteban

Role: CONTACT

Facility Contacts

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Esteban López de Sa, MD

Role: primary

Other Identifiers

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BIOMIN-001

Identifier Type: -

Identifier Source: org_study_id

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