Study for the Validation of a New Biomarker to Determine Predisposition to Infections in Patients With Acute Myocardial Infarction.

Study for the Clinical Validation of a New Biomarker to Determine Predisposition to Infections in Patients With Acute Myocardial Infarction.

Prospective biomedical research study

Study Overview

• Status: Recruiting
• Conditions: Infections in Acute Myocardial Infarction Patients
• Intervention / Treatment: Other: prospective biomedical research study

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Miguel Ángel Llamas Matías; Phone Number: +034 924 951 112; Email: mallamas@crazyscience.es
• Study Contact Backup: Name: Beatriz Salvador Esteban; Email: salvador.bea@gmail.com

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario La Paz
    • Contact: Esteban López de Sa, MD; Email: e.lopezdesa@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study is aimed at those patients who have suffered an AMI or OUT-OF-HOSPITAL CARDIORRESPIRATORY ARREST and are admitted to the Critical Care Unit.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group A low risk of infection	Other: 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	Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical validation of the presence of elevated mitochondrial DNA levels as a prognostic biomarker of infection risk in AMI patients	Level of circulating DNAmit	18-30 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlating mitochondrial DNA levels with the patient's "immune" tolerant status	Refractory state of circulating monocytes/macrophages [pg/mL]	18-30 hours
To determine the relationship between ADNmit levels and infarct location	Infarct location (anterior or non-anterior)	0-24 hours
To determine the relationship between ADNmit levels and Left Ventricular Ejection Fraction	LVEF [%]	0-24 hours
To determine the relationship between ADNmit levels and ultrasensitive troponin I	ultrasensitive troponin I [pg/mL]	0-24 hours
To determine the relationship between ADNmit levels and GRACE Score	GRACE Score [numerical values that determine risk of death: 0-258]	0-24 hours

Collaborators and Investigators

• Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Collaborators: Crazy Science & Business S.L.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 21, 2021
• Primary Completion (ANTICIPATED): July 21, 2022
• Study Completion (ANTICIPATED): July 21, 2023

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (ACTUAL): June 9, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 7, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Myocardial Infarction; Infarction; Infections; Communicable Diseases; Disease Susceptibility
• Other Study ID Numbers: BIOMIN-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No