NCT04578964

Brief Summary

The study aimed to evaluate the association between the obesity grade and the age of the first acute coronary syndrome (ACS). The effect of cardiovascular (CV) risk factors and the age of first ACS in patients with severe obesity was also examined. Consecutive patients with diagnosis of first episode of ACS were prospectively enrolled in 2014 to 2024.Cardiovascular risks of patients will be determined according to clinical and laboratory evaluation and patients were categorized by their body mass indices (BMI). Independent variables that effected the age of first ACS were examined by linear regression analysis

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 2, 2014

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

9.4 years

First QC Date

October 1, 2020

Last Update Submit

January 30, 2023

Conditions

Keywords

acute coronary syndromeageobesityrisk factor, Cardiovascularsmokinggenderhyperlipidemiadiabetes mellituspsychosocial stress

Outcome Measures

Primary Outcomes (1)

  • Determining the effect of cardiovascular risk factors on the mean age of the first acute coronary syndrome

    Detection of the effect of gender, smoking, obesity, diabetes, hypertension, psychological stress, socioeconomic status, migration, dyslipidemia on the age of first acute coronary syndrome episode.

    10 years

Secondary Outcomes (3)

  • Determining the effect of obesity on the mean age of the first acute coronary syndrome

    6 years

  • Determining the effect of migration on the mean age of the first acute coronary syndrome.

    6 years

  • Model for calculating the acute coronary syndrome age

    8 years

Eligibility Criteria

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

First acute coronary syndrome patients admitted to the coronary intensive care unit

You may qualify if:

  • Adult patients with the diagnosis of the first acute coronary syndrome

You may not qualify if:

  • Previous cardiovascular disease
  • Chronic renal disease,
  • Chronic obstructive pulmonary disease,
  • Malignancy,
  • Regularly use of statins, antiplatelets or anticoagulants,
  • Situations where oral communication cannot be established with the patient
  • Situations when coronary angiography (CAG) could not be performed .
  • Patients with findings that might be related to previous MI on electrocardiography (ECG) or echocardiography and total occlusion other than 'culprit' lesion and no critical stenosis on CAG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deniz Demirci

Antalya, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Demirci D, Demirci DE, Chi G. Association between obesity grade and the age of the first acute coronary syndrome: Prospective observational study. Int J Cardiol. 2022 Mar 15;351:93-99. doi: 10.1016/j.ijcard.2021.11.080. Epub 2021 Dec 2.

MeSH Terms

Conditions

Acute Coronary SyndromeObesitySmokingCoitusHyperlipidemiasDiabetes Mellitus

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorSexual BehaviorDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesGlucose Metabolism DisordersEndocrine System Diseases

Central Study Contacts

Deniz Demirci, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 1, 2020

First Posted

October 8, 2020

Study Start

January 2, 2014

Primary Completion

June 1, 2023

Study Completion

June 1, 2024

Last Updated

January 31, 2023

Record last verified: 2023-01

Locations