Infections in Acute Myocardial Infarction PatientsNCT05412732
Study for the Validation of a New Biomarker to Determine Predisposition to Infections in Patients With Acute Myocardial Infarction.
An observational study of Infections in Acute Myocardial Infarction Patients, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
Prospective biomedical research study Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Infections in Acute Myocardial Infarction Patients
- What is being tested?
- prospective biomedical research study
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 21 Jul 2021to 21 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
- Symptoms of cardiac ischaemia.
- New ischaemic patterns in the ECG.
- Development of pathological QW waves on the ECG.
- Obvious suspicion or loss of myocardial viability or new abnormal motility regions in a pattern consistent with ischaemic pathology.
- 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).
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- 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.
Who cannot join
- Patients who meet any of the following criteria shall not be eligible for inclusion in the clinical trial:
- Chronic inflammatory diseases
- Transplantation of any organ (except cornea).
- 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.
- Patients with overt and/or severe immunocompromise
- History of chronic kidney or liver disease (dialysis or creatinine clearance < 30%).
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- Decompensated diabetes
- Active tumour process. Patients considered to be in complete remission may be included in the study.
- Major surgical intervention (in the 3 MONTHS PRIOR to inclusion in the study).
- Pregnancy, childbirth or breastfeeding in the last 3 months.
- Symptomatic patients with type IV heart failure (NYHA).
- Life expectancy of less than 3 months.
- Long-term urinary catheter or vascular catheter wearers
Trial locations and contacts
1 site in 1 country.
Beatriz Salvador Esteban contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
Esteban López de Sa, MD, e.lopezdesa@gmail.com
About this study
Official title: Study for the Clinical Validation of a New Biomarker to Determine Predisposition to Infections in Patients With Acute Myocardial Infarction.
Prospective biomedical research study
Read the 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.
- Being tested
- prospective biomedical research study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prospective biomedical research studyOther
A prospective biomedical study, in which a comparison will be made of the outcome of a specific disease (in this case, AMI).
| Study group | Role | What they receive |
|---|---|---|
| group A low risk of infection | Not described Receives: Other: prospective biomedical research study | |
| group B high risk of infection | Not described Receives: Other: prospective biomedical research study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical validation of the presence of elevated mitochondrial DNA levels as a prognostic biomarker of infection risk in AMI patients
Level of circulating DNAmit
Measured: 18-30 hours
Secondary outcomes (5)
Correlating mitochondrial DNA levels with the patient's "immune" tolerant status
Refractory state of circulating monocytes/macrophages [pg/mL]
Measured: 18-30 hours
To determine the relationship between ADNmit levels and infarct location
Infarct location (anterior or non-anterior)
Measured: 0-24 hours
To determine the relationship between ADNmit levels and Left Ventricular Ejection Fraction
LVEF [%]
Measured: 0-24 hours
To determine the relationship between ADNmit levels and ultrasensitive troponin I
ultrasensitive troponin I [pg/mL]
Measured: 0-24 hours
To determine the relationship between ADNmit levels and GRACE Score
GRACE Score [numerical values that determine risk of death: 0-258]
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start21 Jul 2021
- Primary completion21 Jul 2022 (estimated)
- Study completion21 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections in Acute Myocardial Infarction PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Crazy Science & Business S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412732
- Sponsor's protocol ID
- BIOMIN-001
- Status last verified
- Jun 2022
- First submitted
- 19 May 2022
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for the Clinical Validation of a New Biomarker to Determine Predisposition to Infections in Patients With Acute Myocardial Infarction.
- ClinicalTrials.gov ID
- NCT05412732
- Acronym / sponsor ID
- BIOMIN-001
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Crazy Science & Business S.L.
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 21 Jul 2022 (estimated)
- Study completion
- 21 Jul 2023 (estimated)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A low risk of infection | – | Other: prospective biomedical research study |
| group B high risk of infection | – | Other: prospective biomedical research study |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (13 listed)
- Patients who meet any of the following criteria shall not be eligible for inclusion in the clinical trial:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prospective biomedical research studyA prospective biomedical study, in which a comparison will be made of the outcome of a specific disease (in this case, AMI). | Other | group A low risk of infection, group B high risk of infection |
Primary outcome
Clinical validation of the presence of elevated mitochondrial DNA levels as a prognostic biomarker of infection risk in AMI patients
Time frame: 18-30 hours
Level of circulating DNAmit
5 secondary outcomes
Correlating mitochondrial DNA levels with the patient's "immune" tolerant status
Time frame: 18-30 hours
To determine the relationship between ADNmit levels and infarct location
Time frame: 0-24 hours
To determine the relationship between ADNmit levels and Left Ventricular Ejection Fraction
Time frame: 0-24 hours
To determine the relationship between ADNmit levels and ultrasensitive troponin I
Time frame: 0-24 hours
To determine the relationship between ADNmit levels and GRACE Score
Time frame: 0-24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatriz Salvador Esteban contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections in Acute Myocardial Infarction Patients, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miguel Ángel Llamas Matías (+034 924 951 112, mallamas@crazyscience.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical validation of the presence of elevated mitochondrial DNA levels as a prognostic biomarker of infection risk in AMI patients (time frame: 18-30 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.