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Myocardial InfarctionAGLIANICONCT05112731

Role of Glycation and Inflammation in Acute Ischemic Heart Disease

An observational study of Myocardial Infarction and Glycation End Products, Advanced, run by GEK Srl at 1 site in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study requires the consecutive enrollment of 60 patients following the first event of acute myocardial infarction, evaluating B-Cell Activating Factor (BAFF) and methylglyoxal (MGO) levels in the acute setting (pre-reperfusion) and 3 months after reperfusion. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
BAFF and MGO
How many people
16 participants
Where
1 siteItaly
Study dates
1 Feb 2022to 31 Dec 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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 60 consecutive patients admitted in the ED for first myocardial infarction who meet eligibility criteria

Who may be able to join

  • hospitalization for first myocardial infarction (STEMI or NSTEMI)
  • age between 18 and 80

Who cannot join

  • uncompensated T2DM (HbA1c >53mmol/mol)
  • use of anti-CD20 treatment
  • chronic anti-inflammatory treatment for autoimmune disease (i.e. DMARDs, high dose FANS, cortisonic drugs)

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Istituto Clinico Città Studi

    Milan, 20131

Other trials in Italy

About this study

Official title: Action of Glycation and Inflammation in Operative Ischemic Heart Disease

This study requires the consecutive enrollment of 60 patients following the first event of acute myocardial infarction, evaluating B-Cell Activating Factor (BAFF) and methylglyoxal (MGO) levels in the acute setting (pre-reperfusion) and 3 months after reperfusion.

Read the detailed description

This study requires the consecutive enrollment of 60 patients at admission for first acute myocardial infarction. At enrollment, before reperfusion, a blood sample is obtained to measure B-Cell Activating Factor (BAFF) and methylglyoxal (MGO) levels in the acute setting. This measure is then repeated at follow-up visit 3 months after reperfusion. The aim of the study is to identify specific subsets of patients and evaluate biomarkers variations.

Being tested
BAFF and MGO
Keywords
AGEs, BAFF, Myocardial Infarction
Medical subject headings
Myocardial Infarction, Inflammation, Heart Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAFF and MGODiagnostic test

    measurement of BAFF and MGO levels before reperfusion and after 3 months

Study groups in NCT05112731
Study groupRoleWhat they receive
First Ischemic Cardiac EventMeasurement of BAFF and MGO at hospitalization (before reperfusion) and after 3 months during follow-up
Receives: Diagnostic Test: BAFF and MGO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Identification of Inflammatory Biomarkers (BAFF) linked to ischemic event and outcome

    elevation of BAFF levels

    Measured: Day 0

  2. Identification of Glycation Biomarkers (MGO) linked to ischemic event and outcome

    elevation of MGO levels

    Measured: Day 0

Secondary outcomes (2)

  1. Identification of biomarkers variations (BAFF) complications and outcome

    variation of BAFF from baseline

    Measured: After 3 months

  2. Identification of biomarkers variations (MGO) complications and outcome

    variation of MGO from baseline

    Measured: After 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2021
  2. Study start1 Feb 2022
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Why it stopped: Missing enrollment at study centre

Resources

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
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05112731
Sponsor's protocol ID
2021AGLIANICO
Acronym
AGLIANICO
Status last verified
Feb 2024
First submitted
20 Oct 2021
Last updated
16 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Evans JDW, Dobbin SJH, Pettit SJ, Di Angelantonio E, Willeit P. High-Sensitivity Cardiac Troponin and New-Onset Heart Failure: A Systematic Review and Meta-Analysis of 67,063 Patients With 4,165 Incident Heart Failure Events. JACC Heart Fail. 2018 Mar;6(3):187-197. doi: 10.1016/j.jchf.2017.11.003. Epub 2018 Jan 10.

    PubMed 29331272

  • Mariathas M, Allan R, Ramamoorthy S, Olechowski B, Hinton J, Azor M, Nicholas Z, Calver A, Corbett S, Mahmoudi M, Rawlins J, Simpson I, Wilkinson J, Kwok CS, Cook P, Mamas MA, Curzen N. True 99th centile of high sensitivity cardiac troponin for hospital patients: prospective, observational cohort study. BMJ. 2019 Mar 13;364:l729. doi: 10.1136/bmj.l729.

    PubMed 30867154

  • Francis Stuart SD, De Jesus NM, Lindsey ML, Ripplinger CM. The crossroads of inflammation, fibrosis, and arrhythmia following myocardial infarction. J Mol Cell Cardiol. 2016 Feb;91:114-22. doi: 10.1016/j.yjmcc.2015.12.024. Epub 2015 Dec 29.

    PubMed 26739214

  • Zouggari Y, Ait-Oufella H, Bonnin P, Simon T, Sage AP, Guerin C, Vilar J, Caligiuri G, Tsiantoulas D, Laurans L, Dumeau E, Kotti S, Bruneval P, Charo IF, Binder CJ, Danchin N, Tedgui A, Tedder TF, Silvestre JS, Mallat Z. B lymphocytes trigger monocyte mobilization and impair heart function after acute myocardial infarction. Nat Med. 2013 Oct;19(10):1273-80. doi: 10.1038/nm.3284. Epub 2013 Sep 15.

    PubMed 24037091

  • Akhand AA, Hossain K, Mitsui H, Kato M, Miyata T, Inagi R, Du J, Takeda K, Kawamoto Y, Suzuki H, Kurokawa K, Nakashima I. Glyoxal and methylglyoxal trigger distinct signals for map family kinases and caspase activation in human endothelial cells. Free Radic Biol Med. 2001 Jul 1;31(1):20-30. doi: 10.1016/s0891-5849(01)00550-0.

    PubMed 11425486

  • Khan MA, Schultz S, Othman A, Fleming T, Lebron-Galan R, Rades D, Clemente D, Nawroth PP, Schwaninger M. Hyperglycemia in Stroke Impairs Polarization of Monocytes/Macrophages to a Protective Noninflammatory Cell Type. J Neurosci. 2016 Sep 7;36(36):9313-25. doi: 10.1523/JNEUROSCI.0473-16.2016.

    PubMed 27605608

  • Blackburn NJR, Vulesevic B, McNeill B, Cimenci CE, Ahmadi A, Gonzalez-Gomez M, Ostojic A, Zhong Z, Brownlee M, Beisswenger PJ, Milne RW, Suuronen EJ. Methylglyoxal-derived advanced glycation end products contribute to negative cardiac remodeling and dysfunction post-myocardial infarction. Basic Res Cardiol. 2017 Sep 1;112(5):57. doi: 10.1007/s00395-017-0646-x.

    PubMed 28864889

Questions about this trial

What is this clinical trial studying?

An observational study of Myocardial Infarction and Glycation End Products, Advanced, run by GEK Srl at 1 site in Italy.

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 3 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: stopped early, as of the sponsor's last update on 16 Feb 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 Italy. 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?

The study was stopped early (reason given: Missing enrollment at study centre). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identification of Inflammatory Biomarkers (BAFF) linked to ischemic event and outcome (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05112731, which also lists 7 linked publications.

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 16 Feb 2024.

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