Clinical trial NCT05112731: Role of Glycation and Inflammation in Acute Ischemic Heart Disease
Official title: Action of Glycation and Inflammation in Operative Ischemic Heart Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Myocardial Infarction
Glycation End Products, Advanced
Inflammation
Heart Injuries
Heart Inflammation
Keywords: AGEs
BAFF
Myocardial Infarction
Lead sponsor: GEK Srl
Sponsor class: INDUSTRY
Collaborators: name: Istituto Clinico Città Studi
First posted: 2021-11-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 60 consecutive patients admitted in the ED for first myocardial infarction who meet eligibility criteria

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Identification of Inflammatory Biomarkers (BAFF) linked to ischemic event and outcome
timeFrame: Day 0
measure: Identification of Glycation Biomarkers (MGO) linked to ischemic event and outcome
timeFrame: Day 0
Secondary outcomes:
measure: Identification of biomarkers variations (BAFF) complications and outcome
timeFrame: After 3 months
measure: Identification of biomarkers variations (MGO) complications and outcome
timeFrame: After 3 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Istituto Clinico Città Studi
Study officials:
affiliation: Istituto Clinico Città Studi
name: Michele Bianchi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Clinico Città Studi
name: Altin Palloshi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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.
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.