Role of Glycation and Inflammation in Acute Ischemic Heart Disease

Myocardial Infarction Clinical Trial

— AGLIANICO  

Official title:

Action of Glycation and Inflammation in Operative Ischemic Heart Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05112731
• Other study ID #: 2021AGLIANICO
• Status: Terminated
• Start date: February 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: GEK Srl
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Heart Injuries
• Infarction
• Inflammation
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Diagnostic Test:
• BAFF and MGO
measurement of BAFF and MGO levels before reperfusion and after 3 months

Locations

Country	Name	City	State
Italy	Istituto Clinico Città Studi	Milano

Sponsors (2)

Lead Sponsor	Collaborator
GEK Srl	Istituto Clinico Città Studi

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of Inflammatory Biomarkers (BAFF) linked to ischemic event and outcome	elevation of BAFF levels	Day 0
Primary	Identification of Glycation Biomarkers (MGO) linked to ischemic event and outcome	elevation of MGO levels	Day 0
Secondary	Identification of biomarkers variations (BAFF) complications and outcome	variation of BAFF from baseline	After 3 months
Secondary	Identification of biomarkers variations (MGO) complications and outcome	variation of MGO from baseline	After 3 months