Impact of New Anthropometric Indices on Outcomes After Cardiac Surgery

July 26, 2022 updated by: MERVE SAHINGOZ, TC Erciyes University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • open heart surgery
  • voluntary patients

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: within 30 days of the procedure
Number of death at 30 days after surgery
within 30 days of the procedure
postoperative stroke
Time Frame: within 30 days of the procedure
Number of patients with postoperative stroke
within 30 days of the procedure
cardiac arrest
Time Frame: within 30 days of the procedure
number of patients with cardiac arrest
within 30 days of the procedure
new atrial fibrillation/flutter
Time Frame: within 30 days of the procedure
Number of Partients with new atrial fibrillation/flutter
within 30 days of the procedure
permanent rhythm device insertion
Time Frame: within 30 days of the procedure
Number of Patients requiring insertion of a permanent device
within 30 days of the procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
prolonged ventilation
Time Frame: within 30 days of the procedure
number of patients experiencing prolonged postoperative pulmonary ventilation (>24 hours)
within 30 days of the procedure
sepsis /deep sternal infection
Time Frame: within 30 days of the procedure
number of patients with sepsis, deep sternal wound infection or mediastinitis
within 30 days of the procedure
pulmonary complications
Time Frame: within 30 days of the procedure
number of patients with pneumonia or pleural effusion
within 30 days of the procedure
renal failure / renal dialysis
Time Frame: within 30 days of the procedure
number of patient with acute renal failure or worsening renal function result
within 30 days of the procedure
total intensive care unit (ICU) hours
Time Frame: within 30 days of the procedure
total intensive care unit (ICU) hours
within 30 days of the procedure
intensive care unit (ICU) readmissions
Time Frame: within 30 days of the procedure
number of patients with intensive care unit readmission
within 30 days of the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TC Erciyes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 27, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022/02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings