NCT05246215

Brief Summary

An acute ST-elevation myocardial infarction occurs due to occlusion of one or more coronary arteries, causing transmural myocardial ischemia which in turn results in myocardial injury or necrosis. Acute myocardial infarction (AMI) may lead to the development of heart failure (HF). Accessible diagnostic tools commonly used in HF such as natriuretic peptides and (NYHA) classification reflect already overt clinical HF. Troponin and creatine kinase reflect myocardial damage, but their usefulness in predicting long-term LVR is limited. Recent guidelines on HF management stressed that HF onset may be delayed or prevented through certain Interventions, such as pharmacotherapy ,post infarction rehabilitation, or modification of HF risk factors. Therefore, it is important to identify potential markers, which would be more informative of HF preclinical stages to recognize patients with an increased risk of HF onset, and to start treatment in advance (1) Gal-3 participates in inflammation and pro fibrotic pathways, while sST2 is a biomarker of inflammation, cardiac mechanical strain, and tissue fibrosis, both of which may predict LVR (2). sST is a biomarker of inflammation, cardiac mechanical strain, and tissue fibrosis(3). B\_type natriuretic peptide (BNP) is elevated in acute myocardial infarction and is a quantitative biochemical marker related to the extent of infarction and left ventricular systolic dysfunction(4).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 18, 2022

Status Verified

February 1, 2022

Enrollment Period

3.8 years

First QC Date

February 9, 2022

Last Update Submit

February 17, 2022

Conditions

Keywords

Galectin-3

Outcome Measures

Primary Outcomes (1)

  • investigate the association of Gal-3, sST2 and BNP concentrations and the development of clinically overt HF in patients after ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention

    7 months

Study Arms (3)

STEMI group.

60 participants of patients with STEMI treated with primary percutaneous coronary intervention (pPCI).

healthy group.

15 participants of healthy people as a case control.

Stable angina group.

15 participants of patients stable angina

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Assuit University Hospital.

You may qualify if:

  • Age ≥ 18 years.
  • Hospital admission due to first-time STEMI treated with pPCI.

You may not qualify if:

  • History of previous acute coronary syndrome, Previously diagnosed HF or asymptomatic LV dysfunction with LVEF \<50% or previously diagnosed significant valvular disease or any other previously diagnosed structural heart disease Severe renal dysfunction, Severe liver disease, Chronic inflammatory disease, Current neoplastic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionHeart FailureAngina, Stable

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisAngina PectorisChest PainPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Aya Khalifa Abdelzaher

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor.

Study Record Dates

First Submitted

February 9, 2022

First Posted

February 18, 2022

Study Start

March 1, 2022

Primary Completion

December 1, 2025

Study Completion

March 1, 2026

Last Updated

February 18, 2022

Record last verified: 2022-02