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Imaging-based Diagnosis of Diffuse Coronary Artery Disease and Quantification of Cardiac Remodeling in Obesity

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ClinicalTrials.gov Identifier: NCT03046823
Recruitment Status : Completed
First Posted : February 8, 2017
Last Update Posted : June 25, 2020
Sponsor:
Collaborator:
Singapore General Hospital
Information provided by (Responsible Party):
National Heart Centre Singapore

Study Description
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Brief Summary:

The study aims to:

  1. Characterize coronary artery disease (CAD) using CT Angiography (CTA) and scaling power law in 100 patients with obesity
  2. Characterize cardiac remodeling using curvedness-based MRI in 100 patients with obesity
  3. Compare the differences of cardiac and vascular remodeling in patients with metabolic syndrome and those without

Condition or disease
Obesity

Detailed Description:

Background and Objectives:

Obesity is a common [affecting about 33% in the general adult population in US] metabolic disorder and it is increasing in prevalence in Singapore (about 10% of general adult population). As obesity is associated with cardiovascular disease (i.e., diffused coronary artery disease, DCAD) and leads to heart remodeling and heart failure, timely and accurate diagnosis of diffused coronary artery disease and its related cardiac remodeling in obesity is clinically urgently needed and this study aims to:

  1. Characterize coronary artery disease (CAD) using CTA and scaling power law in 100 patients with obesity
  2. Characterize cardiac remodeling using curvedness-based MRI in 100 patients with obesity
  3. Compare the differences of cardiac and vascular remodeling in patients with metabolic syndrome and those without

Methodologies: 100 patients with obesity will be recruited for this study. All recruited patients will undergo fasting blood test for diagnosing metabolic syndrome. After that, they will undergo CTA and MRI within 1-2 weeks in-between. Patients' CTA images will be segmented and transformed to build 3D coronary artery models. The application of novel scaling power laws on these models will be used to diagnose diffuse CAD. Based on patients MRI images, the cardiac remodeling will be assessed with a novel curvedness-based imaging analysis method. The differences of cardiac and vascular remodeling in patients with metabolic syndrome and those without will be compared and analyzed.

In addition, subjects shall undergo ultrasound examination of the heart (echocardiogram), carotids and forearm arteries. Doppler and tissue-Doppler echocardiography constitutes the gold standard for cardiac diastolic function assessment. The findings shall be correlated with diastolic cine MRI findings. Carotid and forearm artery ultrasound allows investigation of vessel distensibility, carotid intimal thickness, pulse wave velocity, central arterial blood pressure estimation as well as endothelial function (via flow-mediated dilation). Perturbations of these parameters may be correlated with functional abnormalities on cardiac MRI and coronary disease on CT.

Subjects shall undergo fasting blood tests for metabolic profiling. The tests include blood levels of creatinine, electrolytes, insulin, glycated haemoglobin, fasting lipids, fasting sugar and postprandial sugar (75 g standard oral glucose load). Additionally blood samples shall be stored for potential future studies.

Clinical Significance: If success, this study in obesity should advance understanding of obesity-related CAD and cardiac and vessel remodeling, and further translate into improved diagnosis and treatment in obese patients.

Clinical Significance: If success, this study in obesity should advance understanding of obesity-related CAD and cardiac remodeling, and further translate into improved diagnosis and treatment in obese patients.

Study Design
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Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Imaging-based Diagnosis of Diffuse Coronary Artery Disease and Quantification of Cardiac Remodeling in Obesity
Study Start Date : June 2014
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Diagnosis of diffuse coronary artery disease using imaging techniques and quantification of cardiac remodeling in obesity [ Time Frame: 36 months ]
    Imaging-based techniques used are MRI, CTA and Echocardiogram. Fasting blood tests will be carried out to determine metabolic syndrome. Cardiac and vascular remodeling in participants with metabolic syndrome and those without will be compared and analyzed.


Biospecimen Retention:   Samples Without DNA
blood specimen for future research

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Total recruitment number: 100 Participants' age limit of 21 to 80.
Criteria

Inclusion Criteria:

  1. Aged 21-80.
  2. with obesity BMI ≥27 .
  3. Written informed consent obtained

Exclusion Criteria:

  1. Individuals unable to provide informed consent.
  2. Non-cardiac illness with life expectancy <2 years.
  3. Pregnant state.
  4. Allergy to iodinated contrast.
  5. Significant arrhythmia; heart rate ≥ 100 beats/min; systolic blood pressure ≤90 mmHg.
  6. Renal dysfunction (Glomerular filtration rate (GFR) <45 mL/min/1.73m2).
  7. Contraindication to beta blockers or nitroglycerin.
  8. Canadian Cardiovascular Society class IV angina.
  9. with Cardiac pacemaker
  10. with brain aneurysm or clips
  11. with Electronic implants or prosthesis
  12. with Eye metal foreign body injury
  13. Severe claustrophobia
  14. Thyroid dysfunction
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03046823


Locations
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Singapore
National Heart Centre
Singapore, Singapore, 169609
Sponsors and Collaborators
National Heart Centre Singapore
Singapore General Hospital
Investigators
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Principal Investigator: RU SAN TAN National Heart Centre
More Information
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Responsible Party: National Heart Centre Singapore
ClinicalTrials.gov Identifier: NCT03046823    
Other Study ID Numbers: 2014/501/C
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Obesity
Overnutrition
Nutrition Disorders
Overweight
 Body Weight
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases