AGLIANICO: Role of Glycation and Inflammation in Acute Ischemic Heart Disease

Sponsor
GEK Srl (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05112731
Collaborator
Istituto Clinico Città Studi (Other)
60
1
10
6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: BAFF and MGO

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Action of Glycation and Inflammation in Operative Ischemic Heart Disease
Actual Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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
measurement of BAFF and MGO levels before reperfusion and after 3 months

Outcome Measures

Primary Outcome Measures

  1. Identification of Inflammatory Biomarkers (BAFF) linked to ischemic event and outcome [Day 0]

    elevation of BAFF levels

  2. Identification of Glycation Biomarkers (MGO) linked to ischemic event and outcome [Day 0]

    elevation of MGO levels

Secondary Outcome Measures

  1. Identification of biomarkers variations (BAFF) complications and outcome [After 3 months]

    variation of BAFF from baseline

  2. Identification of biomarkers variations (MGO) complications and outcome [After 3 months]

    variation of MGO from baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istituto Clinico Città Studi Milano Italy 20131

Sponsors and Collaborators

  • GEK Srl
  • Istituto Clinico Città Studi

Investigators

  • Principal Investigator: Michele Bianchi, MD, Istituto Clinico Città Studi
  • Principal Investigator: Altin Palloshi, MD, Istituto Clinico Città Studi

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
GEK Srl
ClinicalTrials.gov Identifier:
NCT05112731
Other Study ID Numbers:
  • 2021AGLIANICO
First Posted:
Nov 9, 2021
Last Update Posted:
Jul 8, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by GEK Srl
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 8, 2022