ClinicalTrials.gg
RecruitingNCT06446895IMACORN-INFLIUpdated Jun 6, 2024

Biomarkers of Inflammation and Endothelial Dysfunction in Patients With Myocardial Infarction With Non-obstructive Coronary Arteries

An observational study in Myocardial Infarction, MINOCA and Inflammation, sponsored by Hospital Universitario Getafe. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-06.

Primary conditionMINOCARegistry: Myocardial InfarctionReclassifiedWhy we changed it
Registry
Myocardial Infarction — the first condition term the registry derived for this study.
ClinicalTrials.gg
MINOCA
Why
  1. The study's listed conditions name MINOCA, a narrower term within Myocardial Infarction.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Hospital Universitario Getafe · Observational

From the registry’s dates

  • Started Oct 2020; still recruiting 6 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Myocardial Infarction
  • MINOCA
  • Inflammation
  • Biomarkers
  • Endothelial Dysfunction

Browse trials for

03

In context

MINOCA Reclassified

29 studies on the registry are indexed under MINOCA; 18 are open to participants now.

This study's planned enrollment of 400 is below the median of 500 across 20 observational studies indexed under MINOCA.

Browse MINOCA studies →

Lead sponsor

Hospital Universitario Getafe is the lead sponsor of 29 studies on the registry; 3 are open to participants now.

Compared within MINOCA, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Myocardial Infarction. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients older than 18 years old admitted to our hospital with Myocardial Infarction and undergo a coronariography.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients admitted with Myocardial Infarction and undergo a coronariography
  • Patients must sign .

Exclusion criteria

Exclusion Criteria:

  • Patients who don´t sign
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • MICAD

    Patients with Myocardial Infarction and Obstructive Coronary Arteries

    Diagnostic Test: Coronariography

  • MINOCA

    Patients with Myocardial Infarction and Non-obstructive Coronary Arteries

    Diagnostic Test: Coronariography

Interventions

  • Diagnostic testCoronariography

    Patients were classified as MICAD or MINOCA by the presence or absence of an epicardial vessel with ≥50% stenosis after performing a coronariography.

06

What researchers measure

Primary outcomes

  1. 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.

    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.

  2. Levels of endhotelial disfunction biomarkers

    Levels of asymmetric dimethylarginine will be determined

    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.

  3. Levels of high-sensitivity C-reactive protein (mg/L)

    Levels of high-sensitivity C-reactive protein (mg/L) will be determined.

    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.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2020 to primary completion in May 2024, 43 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 27, 2024
First posted
Jun 6, 2024
StartActual
Oct 1, 2020
Primary completionActual
May 22, 2024
CompletionEst.
May 31, 2025
Last update
Jun 6, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06446895
Lead sponsor
Hospital Universitario Getafe
Responsible party
maria jesus espinosa pascual (Cardiologist, Hospital Universitario Getafe) — Principal investigator
First posted
Jun 6, 2024
Start date
Oct 1, 2020
Primary completion
May 22, 2024
Completion
May 31, 2025 (estimated)
Last update
Jun 6, 2024

Study contacts

MARIA JESUS ESPINOSA, MD
Contact
mariajesusespinosapascual@gmail.com
636581691
JOAQUIN ALONSO, PHD
Contact
joaquinjalonso@gmail.com
609208299

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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