NCT06561815

Brief Summary

This study addresses the critical issue of obesity and its impact on patients with acute coronary syndrome (ACS). While obesity is a known risk factor for cardiovascular diseases, emerging evidence suggests that obese patients with coronary artery disease may have better survival outcomes-a phenomenon known as the \"obesity paradox.\" Our research aims to explore this paradox by examining the body composition of ACS patients using bioimpedance analysis (BIA). We will evaluate parameters such as lean mass, body fat, and fluid volume to assess their relationship with clinical outcomes, including mortality and the incidence of heart and kidney failure. By focusing on body composition rather than just BMI, this study seeks to provide a more accurate understanding of how these factors influence patient outcomes. Conducted at a major hospital in Argentina, the study will contribute valuable insights into the role of body composition in the prognosis of ACS, potentially informing more personalized treatment strategies.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 11, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 20, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

2.6 years

First QC Date

August 13, 2024

Last Update Submit

August 15, 2024

Conditions

Keywords

Obesity ParadoxAcute Coronary SyndromeBody Composition

Outcome Measures

Primary Outcomes (1)

  • cardiovascular death

    Death attributed to cardiovascular conditions.

    1 year

Other Outcomes (1)

  • MACE

    1 year

Eligibility Criteria

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

All patients hospitalized in the Cardiovascular Care Unit with a diagnosis of acute coronary syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas "José de San Martín"

Buenos Aires, Buenos Aires, C1120AAG, Argentina

RECRUITING

MeSH Terms

Conditions

Angina, UnstableObesityAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Central Study Contacts

Diego Costa, MD, MSc.

CONTACT

Ricardo Pérez de la Hoz, MD, MSc, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 13, 2024

First Posted

August 20, 2024

Study Start

February 11, 2023

Primary Completion

August 30, 2025

Study Completion

November 30, 2025

Last Updated

August 20, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations