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AzTrials

Coronary Artery DiseaseNCT05403294

Impact of New Anthropometric Indices on Outcomes After Cardiac Surgery

An observational study of Coronary Artery Disease and Cardiometabolic Risk Factors, run by TC Erciyes University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Obesity is associated with a number of risk factors for cardiovascular disease. Body mass index (BMI) is the most commonly recommended and used anthropometric measure to classify general obesity in clinical and epidemiological studies. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
How many people
240 participants
Where
No sites listed yet
Study dates
27 Jul 2022to 1 Nov 2022
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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients over the age of 18 who have undergone open heart surgery

Who may be able to join

  • open heart surgery
  • voluntary patients

Who cannot join

  • emergency surgery
  • off-pump or robotic surgery
  • surgery requiring deep hypothermic circulatory arrest
  • reluctant patients

About this study

Obesity is associated with a number of risk factors for cardiovascular disease. Body mass index (BMI) is the most commonly recommended and used anthropometric measure to classify general obesity in clinical and epidemiological studies. It is widely accepted that obesity increases the risk of heart disease and is thought to be a risk factor for adverse outcomes after cardiac surgery. However, recent studies show paradoxical results, wherein obese patients can experience fewer adverse events and lower mortality than patients with normal-low body mass index(BMI) . The discriminative capacity of BMI has been criticized because it cannot distinguish muscle mass from fat mass, or reflect fat distribution . Alternatively, abdominal obesity indices, such as waist circumference (WC) and waist-to-height ratio (WHtR), have been suggested to be better predictor of cardiometabolic abnormalities because they modulate the limitation of BMI. However, they were insufficient in studies.For this reason, scientists turned to find a new anthropometric formula that could better detect obesity-related mortality and morbidity and they developed 2 new methods. Body Shape İndex (ABSI) is calculated using waist circumference, BMI and height parameters. Body Roundness İndex (BRI) is calculated using waist circumference and height parameters. These new indices may reflect visceral adiposity and strongly predict cardiovascular risk, postsurgical outcomes and resource utilisation.

Medical subject headings
Coronary Artery Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mortality

    Number of death at 30 days after surgery

    Measured: within 30 days of the procedure

  2. postoperative stroke

    Number of patients with postoperative stroke

    Measured: within 30 days of the procedure

  3. cardiac arrest

    number of patients with cardiac arrest

    Measured: within 30 days of the procedure

  4. new atrial fibrillation/flutter

    Number of Partients with new atrial fibrillation/flutter

    Measured: within 30 days of the procedure

  5. permanent rhythm device insertion

    Number of Patients requiring insertion of a permanent device

    Measured: within 30 days of the procedure

Secondary outcomes (6)

  1. prolonged ventilation

    number of patients experiencing prolonged postoperative pulmonary ventilation (>24 hours)

    Measured: within 30 days of the procedure

  2. sepsis /deep sternal infection

    number of patients with sepsis, deep sternal wound infection or mediastinitis

    Measured: within 30 days of the procedure

  3. pulmonary complications

    number of patients with pneumonia or pleural effusion

    Measured: within 30 days of the procedure

  4. renal failure / renal dialysis

    number of patient with acute renal failure or worsening renal function result

    Measured: within 30 days of the procedure

  5. total intensive care unit (ICU) hours

    total intensive care unit (ICU) hours

    Measured: within 30 days of the procedure

  6. intensive care unit (ICU) readmissions

    number of patients with intensive care unit readmission

    Measured: within 30 days of the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2022
  2. Study start27 Jul 2022 (estimated)
  3. Primary completion1 Oct 2022 (estimated)
  4. Study completion1 Nov 2022 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05403294
Sponsor's protocol ID
2022/02
Status last verified
Jul 2022
First submitted
2 May 2022
Last updated
28 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Cardiometabolic Risk Factors, run by TC Erciyes University.

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 2 inclusion and 4 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 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mortality (time frame: within 30 days of the procedure). The study lists 5 primary outcomes in all. 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 NCT05403294.

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 28 Jul 2022.

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