Role of Glycation and Inflammation in Acute Ischemic Heart Disease (AGLIANICO)

February 15, 2024 updated by: GEK Srl

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20131
        • Istituto Clinico Città Studi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of Inflammatory Biomarkers (BAFF) linked to ischemic event and outcome
Time Frame: Day 0
elevation of BAFF levels
Day 0
Identification of Glycation Biomarkers (MGO) linked to ischemic event and outcome
Time Frame: Day 0
elevation of MGO levels
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of biomarkers variations (BAFF) complications and outcome
Time Frame: After 3 months
variation of BAFF from baseline
After 3 months
Identification of biomarkers variations (MGO) complications and outcome
Time Frame: After 3 months
variation of MGO from baseline
After 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GEK Srl

Collaborators

Istituto Clinico Città Studi

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

October 20, 2021

First Submitted That Met QC Criteria

October 28, 2021

First Posted (Actual)

November 9, 2021

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021AGLIANICO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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