NCT06546228

Brief Summary

Worldwide, Ischemic heart disease is the single most common fatal disease. One of the most common causes of acute myocardial infarction is represented by obesity. Numerous cardio metabolic variables play a key role in incidence of adverse cardiovascular outcomes. The purpose of this research was to investigate the factors allowing to acute coronary syndrome, related to the metabolic status, to help guide each patient toward early preventing behaviors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
652

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 13, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2024

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

July 12, 2024

Last Update Submit

August 7, 2024

Conditions

Acute Myocardial InfarctionRevascularization

Outcome Measures

Primary Outcomes (1)

  • Incidence of Acute Myocardial Infarction (AMI)

    Occurrence of AMI. Unit of measure: Medical records, electrocardiogram (ECG), cardiac biomarkers

    7 years

Secondary Outcomes (2)

  • Change in Left Ventricular Ejection Fraction (LVEF)

    7 years

  • Incidence of Cardiovascular Death

    7 years

Interventions

No intervention. Only observational.OTHER

Only collection of data or parameters already required by the medical examination programmed.

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized for acute coronary syndrome (ACS)

You may qualify if:

  • Patients met the criteria for Acute Coronary Syndrome (ACS) as defined by the Joint European Society of Cardiology/American College of Cardiology Committee.
  • Patients underwent immediate coronary revascularization (primary PCI) for ST-Elevation Myocardial Infarction (STEMI).
  • Patients underwent coronary revascularization (early PCI) within 24 hours for Non-ST-Elevation Myocardial Infarction (NSTEMI).
  • Patients underwent diagnostic coronary angiography following coronary artery bypass graft surgery (CABG).

You may not qualify if:

  • Known coronary artery disease or previous ACS.
  • PCI following CABG.
  • Cardiogenic shock.
  • Atrial fibrillation.
  • Peripheral artery disease.
  • Severe cardiac valve disease.
  • Prosthetic aorta.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera Universitaria G. Martino

Messina, Italy

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2024

First Posted

August 9, 2024

Study Start

January 13, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Anonymous data

Locations

IT(1)