Role of Glycation and Inflammation in Acute Ischemic Heart Disease

NCT05112731 | Terminated

• 1 other identifier: 2021AGLIANICO
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myocardial Infarction; Glycation End Products, Advanced; Inflammation; Heart Injuries; Heart Inflammation

Keywords

AGEs; BAFF; Myocardial Infarction

Outcome Measures

Primary Outcomes (2)

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

  elevation of BAFF levels

  Day 0

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

  elevation of MGO levels

  Day 0

Secondary Outcomes (2)

• Identification of biomarkers variations (BAFF) complications and outcome

  After 3 months

• Identification of biomarkers variations (MGO) complications and outcome

  After 3 months

Study Arms (1)

First Ischemic Cardiac Event

Measurement of BAFF and MGO at hospitalization (before reperfusion) and after 3 months during follow-up

Diagnostic Test: BAFF and MGO

Interventions

BAFF and MGO DIAGNOSTIC_TEST

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

First Ischemic Cardiac Event

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• GEK Srl: lead
• Istituto Clinico Città Studi: collaborator

Study Sites (1)

Istituto Clinico Città Studi

Milan, 20131, Italy

Location

Related Publications (7)

• 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.

  PMID: 29331272 BACKGROUND

• 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.

  PMID: 30867154 BACKGROUND

• 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.

  PMID: 26739214 BACKGROUND

• 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.

  PMID: 24037091 BACKGROUND

• 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.

  PMID: 11425486 BACKGROUND

• 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.

  PMID: 27605608 BACKGROUND

• 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.

  PMID: 28864889 BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction; Inflammation; Heart Injuries

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Thoracic Injuries; Wounds and Injuries

Study Officials

• Michele Bianchi, MD

  Istituto Clinico Città Studi

  PRINCIPAL INVESTIGATOR

• Altin Palloshi, MD

  Istituto Clinico Città Studi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 9, 2021
• Study Start: February 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 16, 2024

Record last verified: 2024-02

Locations

IT (1)