Myocardial InfarctionIMACORN-INFLINCT06446895
Biomarkers of Inflammation and Endothelial Dysfunction in Patients With Myocardial Infarction With Non-obstructive Coronary Arteries
An observational study of Myocardial Infarction and MINOCA, run by Hospital Universitario Getafe at 1 site in Spain.
Trial summary
Around 10% of patients with myocardial infarction (MI) present with nonobstructive coronary arteries (MINOCA) which pathophysiology is often uncertain. The aim of the study is to evaluate inflammation and endothelial dysfunction biomarkers in MINOCA patients during both acute and stable phases, comparing them with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, MINOCA, Inflammation
- What is being tested?
- Coronariography
- How many people
- 400 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2020to 31 May 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients older than 18 years old admitted to our hospital with Myocardial Infarction and undergo a coronariography.
Who may be able to join
- Patients admitted with Myocardial Infarction and undergo a coronariography
- Patients must sign informed consent.
Who cannot join
- Patients who don´t sign informed consent
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Getafe
Getafe, Madrid, 28905
MARIA JESUS ESPINOSA PASCUAL, MD, 636581691, mariajesusespinosapascual@gmail.com
JOAQUIN ALONSO, PHD, 609208299, joaquinjalonso@gmail.com
About this study
Around 10% of patients with myocardial infarction (MI) present with nonobstructive coronary arteries (MINOCA) which pathophysiology is often uncertain. The aim of the study is to evaluate inflammation and endothelial dysfunction biomarkers in MINOCA patients during both acute and stable phases, comparing them with those with MI and obstructive coronary arteries (MICAD).
Read the detailed description
Prospective observational study in patients with Myocardial Infarction (MI) divided into two groups: MI with obstructive coronary arteries (MICAD) and MI with non-obstructive coronary arteries (MINOCA). Levels of interleukin-6, tumor necrosis factor-alpha, high-sensitivity C- reactive protein, and asymmetric dimethylarginine will be determined at three time points: within the 24 hours from the onset of pain, discharge, and two months after MI. The association of biomarkers, normalized by peak troponin value, with the risk of MINOCA will be evaluated using logistic regression.
- Conditions
- Myocardial Infarction, MINOCA, Inflammation, Biomarkers, Endothelial Dysfunction
- Being tested
- Coronariography
- Medical subject headings
- Myocardial Infarction, MINOCA, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoronariographyDiagnostic test
Patients were classified as MICAD or MINOCA by the presence or absence of an epicardial vessel with ≥50% stenosis after performing a coronariography.
| Study group | Role | What they receive |
|---|---|---|
| MICAD | Patients with Myocardial Infarction and Obstructive Coronary Arteries Receives: Diagnostic Test: Coronariography | |
| MINOCA | Patients with Myocardial Infarction and Non-obstructive Coronary Arteries Receives: Diagnostic Test: Coronariography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of interleukin-6 (pg/ml) and tumor necrosis factor-alpha (pg/ml)
Levels of interleukin-6 (pg/ml) and tumor necrosis factor-alpha (pg/ml) will be determined.
Measured: At three time points: within the 24 hours from the onset of pain, on the 5th day of admission, and two months after MI.
Levels of endhotelial disfunction biomarkers
Levels of asymmetric dimethylarginine will be determined
Measured: At three time points: within the 24 hours from the onset of pain, on the 5th day of admission, and two months after MI.
Levels of high-sensitivity C-reactive protein (mg/L)
Levels of high-sensitivity C-reactive protein (mg/L) will be determined.
Measured: t three time points: within the 24 hours from the onset of pain, on the 5th day of admission, and two months after MI.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start1 Oct 2020
- Primary completion22 May 2024
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Getafe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maria jesus espinosa pascual, Hospital Universitario Getafe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446895
- Sponsor's protocol ID
- IMACORN-INFLI
- Acronym
- IMACORN-INFLI
- Status last verified
- May 2024
- First submitted
- 27 May 2024
- Last updated
- 6 Jun 2024
- 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 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Inflammation and Endothelial Dysfunction in Patients With Myocardial Infarction With Non-obstructive Coronary Arteries
- ClinicalTrials.gov ID
- NCT06446895
- Acronym / sponsor ID
- IMACORN-INFLI / IMACORN-INFLI
- Conditions
- Myocardial Infarction, MINOCA, Inflammation, Biomarkers, Endothelial Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hospital Universitario GetafeUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 6 Jun 2024 (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.
Around 10% of patients with myocardial infarction (MI) present with nonobstructive coronary arteries (MINOCA) which pathophysiology is often uncertain. The aim of the study is to evaluate inflammation and endothelial dysfunction biomarkers in MINOCA patients during both acute and stable phases, comparing them with those with MI and obstructive coronary arteries (MICAD).
Detailed description
Prospective observational study in patients with Myocardial Infarction (MI) divided into two groups: MI with obstructive coronary arteries (MICAD) and MI with non-obstructive coronary arteries (MINOCA). Levels of interleukin-6, tumor necrosis factor-alpha, high-sensitivity C- reactive protein, and asymmetric dimethylarginine will be determined at three time points: within the 24 hours from the onset of pain, discharge, and two months after MI. The association of biomarkers, normalized by peak troponin value, with the risk of MINOCA will be evaluated using logistic regression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MICAD | – | Diagnostic Test: CoronariographyPatients with Myocardial Infarction and Obstructive Coronary Arteries |
| MINOCA | – | Diagnostic Test: CoronariographyPatients with Myocardial Infarction and Non-obstructive Coronary Arteries |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years old admitted to our hospital with Myocardial Infarction and undergo a coronariography.
Key inclusion criteria (2 listed)
- Patients admitted with Myocardial Infarction and undergo a coronariography
- Patients must sign informed consent.
Key exclusion criteria (1 listed)
- Patients who don´t sign informed consent
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 |
|---|---|---|
| CoronariographyPatients were classified as MICAD or MINOCA by the presence or absence of an epicardial vessel with ≥50% stenosis after performing a coronariography. | Diagnostic test | MICAD, MINOCA |
Primary outcome
Levels of interleukin-6 (pg/ml) and tumor necrosis factor-alpha (pg/ml)
Time frame: At three time points: within the 24 hours from the onset of pain, on the 5th day of admission, and two months after MI.
Levels of interleukin-6 (pg/ml) and tumor necrosis factor-alpha (pg/ml) will be determined.
Levels of endhotelial disfunction biomarkers
Time frame: At three time points: within the 24 hours from the onset of pain, on the 5th day of admission, and two months after MI.
Levels of asymmetric dimethylarginine will be determined
Levels of high-sensitivity C-reactive protein (mg/L)
Time frame: t three time points: within the 24 hours from the onset of pain, on the 5th day of admission, and two months after MI.
Levels of high-sensitivity C-reactive protein (mg/L) will be determined.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- 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.
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 Myocardial Infarction and MINOCA, run by Hospital Universitario Getafe 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 2 inclusion and 1 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 6 Jun 2024. 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 MARIA JESUS ESPINOSA, MD (636581691, mariajesusespinosapascual@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of interleukin-6 (pg/ml) and tumor necrosis factor-alpha (pg/ml) (time frame: At three time points: within the 24 hours from the onset of pain, on the 5th day of admission, and two months after MI.). The study lists 3 primary outcomes in all. 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 6 Jun 2024.