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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04578964
Other study ID # 2014-097
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2, 2014
Est. completion date June 1, 2024

Study information

Verified date January 2023
Source Antalya Training and Research Hospital
Contact Deniz Demirci, MD
Phone +905056847321
Email dddemirci@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Description:

In the first stage, the first ACS diagnosis of the patients will be tried to be clarified. It will be tried to clarify whether the patients have had ACS before, according to their history, ecg echo and coronary angiography findings. Patients with previous ACS or uncertain ACS diagnosis will not be included in the study. In the second stage, cardiovascular risk burdens of patients for whom the initial ACS diagnosis is clear will be revealed. Smoking, diabetes mellitus (DM), hypertension (HT), psychological stress, socio-economic status, migration history, cholesterol parameters will be determined. The duration and severity of these risk factors will be determined. In the final model, each risk factor will be examined in detail with its sub-tabs and the effect of each risk factor will be examined separately. Eventually, a model will be developed that allows predicting the first ACS age. The shortcomings of this model and the narrow scope of the definition of the population will be determined and the direction will be determined for the studies that improve these points.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date June 1, 2024
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients with the diagnosis of the first acute coronary syndrome Exclusion Criteria: - 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

Study Design


Locations

Country Name City State
Turkey Deniz Demirci Antalya

Sponsors (1)

Lead Sponsor Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Determining the effect of obesity on the mean age of the first acute coronary syndrome Grouping will be made to obesity degree (Normal, overweight, obesity severe obesity). The first ACS average age of these groups will be compared. Risk factors affecting this average age will not be revealed by linear regression model. 6 years
Secondary Determining the effect of migration on the mean age of the first acute coronary syndrome. Do the patients live in the city where they were born. It will be determined whether he migrated from another city. If there is a migration situation, the reasons will be determined. The migration direction will be determined according to the regions. The impact of migration and migration direction on the first ACS age will be determined. 6 years
Secondary Model for calculating the acute coronary syndrome age Develop a model that calculates the estimated age of ACS on the basis of cardiovascular risk factors. 8 years
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