Ignite Creation Date:
2024-05-06 @ 9:40 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03046823
Status:
COMPLETED
Last Update Posted:
2020-06-25
First Post:
2016-05-31
Brief Title:
Imaging-based Diagnosis of Diffuse Coronary Artery Disease and Quantification of Cardiac Remodeling in Obesity
Sponsor:
National Heart Centre Singapore
Organization:
National Heart Centre Singapore
Study Overview
Official Title:
Imaging-based Diagnosis of Diffuse Coronary Artery Disease and Quantification of Cardiac Remodeling in Obesity
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 ie 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
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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None