Acute Coronary SyndromeNCT04578964
Determining the Age of First Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome and Age Problem, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Age Problem, Risk Factor, Cardiovascular
- How many people
- 2,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2014to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: First acute coronary syndrome patients admitted to the coronary intensive care unit
Who may be able to join
- Adult patients with the diagnosis of the first acute coronary syndrome
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Deniz Demirci
Antalya
Deniz Demirci, MD
About this study
Official title: Determining the Cardiovascular Risk Factors Affecting the Age of First Acute Coronary Syndromes
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
Read the detailed 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.
- Keywords
- acute coronary syndrome, age, obesity, risk factor, Cardiovascular, smoking, gender, hyperlipidemia, diabetes mellitus, psychosocial stress
- Medical subject headings
- Acute Coronary Syndrome, Obesity, Smoking, Coitus, Hyperlipidemias, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (3)
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.
Measured: 6 years
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.
Measured: 6 years
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.
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start2 Jan 2014
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Deniz Demirci, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578964
- Sponsor's protocol ID
- 2014-097
- Status last verified
- Jan 2023
- First submitted
- 1 Oct 2020
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34864079
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Cardiovascular Risk Factors Affecting the Age of First Acute Coronary Syndromes
- ClinicalTrials.gov ID
- NCT04578964
- Acronym / sponsor ID
- 2014-097
- Keywords
- acute coronary syndrome, age, obesity, risk factor, Cardiovascular, smoking, gender, hyperlipidemia, diabetes mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 2 Jan 2014 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- First acute coronary syndrome patients admitted to the coronary intensive care unit
Key inclusion criteria (1 listed)
- Adult patients with the diagnosis of the first acute coronary syndrome
Key exclusion criteria (8 listed)
- Previous cardiovascular disease
- Chronic renal disease,
- Chronic obstructive pulmonary disease,
- Malignancy,
- Regularly use of statins, antiplatelets or anticoagulants,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determining the effect of cardiovascular risk factors on the mean age of the first acute coronary syndrome
Time frame: 10 years
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.
3 secondary outcomes
Determining the effect of obesity on the mean age of the first acute coronary syndrome
Time frame: 6 years
Determining the effect of migration on the mean age of the first acute coronary syndrome.
Time frame: 6 years
Model for calculating the acute coronary syndrome age
Time frame: 8 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Derived from this study: PubMed 34864079Demirci 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Age Problem, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deniz Demirci, MD (+905056847321, dddemirci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining the effect of cardiovascular risk factors on the mean age of the first acute coronary syndrome (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04578964, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.