Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06644651
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Fat Around Heart Arteries As a Measure of Inflammation in Patients with Diabetes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Associations of Pericoronary Adipose Tissue Computed Tomography Attenuation with Coronary Plaque Features and Major Adverse Cardiovascular Events in a Population with Diabetes Mellitus
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PCAT-DM
Brief Summary:
In this prospective study we want to learn about inflammation in the arteries of the heart We will use a heart CT scan CCTA to measure inflammation by looking at the fat tissue surrounding the arteries of the heart We have examined participants with type 2 diabetes who have no heart symptoms using a CCTA at the start of the study and again after 12 months
This study aims to answer the following questions
Can inflammation in the surrounding fat tissue at the baseline CCTA predict the amount and type of plaque and the presence of harmful plaque characteristics present after 12 months paper 1
Does changes in inflammation in the surrounding fat tissue from the baseline to the 12 months CCTA have connections to the amount and type of plaque and the presence of harmful plaque characteristics at the 12 months CCTA paper 1
Is inflammation in the surrounding fat tissue a predictor for the development of cardiovascular events after a follow-up period of 7 years paper 2
Does changes in inflammation in the surrounding fat tissue after 12 months predict the later development of cardiovascular eventw after a follow-up period of 7 years paper 2
This study aims to answer the following questions
Can inflammation in the surrounding fat tissue at the baseline CCTA predict the amount and type of plaque and the presence of harmful plaque characteristics present after 12 months paper 1
Does changes in inflammation in the surrounding fat tissue from the baseline to the 12 months CCTA have connections to the amount and type of plaque and the presence of harmful plaque characteristics at the 12 months CCTA paper 1
Is inflammation in the surrounding fat tissue a predictor for the development of cardiovascular events after a follow-up period of 7 years paper 2
Does changes in inflammation in the surrounding fat tissue after 12 months predict the later development of cardiovascular eventw after a follow-up period of 7 years paper 2
Detailed Description:
Background and significance
Inflammation in the coronary arteries plays a significant role in the development of heart disease particularly in individuals with type 2 diabetes T2D who are at an increased risk However this inflammation has been difficult to detect because the currently used biomarkers have limited accuracy in identifying inflammation in the coronary arteries
Exiting advancement has been made in the field of coronary CT angiography CCTA CCTA enables the measurement of the pericoronary adipose tissue PCAT attenuation which refers to the fat tissue surrounding the coronary arteries PCAT and the coronary arteries have a bidirectional communication and when PCAT is exposed to high inflammation it causes the fat-structure to change These structural changes in PCAT can be detected with a CCTA scan Additionally using a CCTA scan we can assses the plaque characteristics including the amount of plaque burden the type of plaque composition and the presence of high-risk features All of which are known to be associated with major adverse cardiovascular events MACE Furthermore recent studies have shown that PCAT attenuation can predict MACE and cardiac mortality
The PCAT-DM study is a post-hoc analysis from the CARPE-DM study NCT03016910 The goal of this prospective study is to investigate if PCAT attenuation andor PCAT changes are associated with high-risk plaque features plaque composition and burden Furthermore we want to investigate if PCAT attenuation andor PCAT changes can predict development of MACE in a follow-up period of 7 years
Setting and study population
A single-center prospective observational study at Odense University Hospital Svendborg Denmark The study enrollment was initiated in March 2016 and ended in September 2017 The study population consists of cardiovascular asymptomatic participants with type 2 diabetes mellitus
Examinations
A total of 314 patients were examined with a CCTA scan at baseline and after 12 months The following examinations were conducted at baseline
CCTA scan
CAC-score
Blood pressure and pulse frequency
Height weight waist to hip-ratio
Blood samples and urin samples
Medical history After 12 months all of the above examinations was repeated
Journal audits will be performed in the period from September 2024 to January 2025 to examine the number of clinical events according to the primary and secondary outcomes
Inflammation in the coronary arteries plays a significant role in the development of heart disease particularly in individuals with type 2 diabetes T2D who are at an increased risk However this inflammation has been difficult to detect because the currently used biomarkers have limited accuracy in identifying inflammation in the coronary arteries
Exiting advancement has been made in the field of coronary CT angiography CCTA CCTA enables the measurement of the pericoronary adipose tissue PCAT attenuation which refers to the fat tissue surrounding the coronary arteries PCAT and the coronary arteries have a bidirectional communication and when PCAT is exposed to high inflammation it causes the fat-structure to change These structural changes in PCAT can be detected with a CCTA scan Additionally using a CCTA scan we can assses the plaque characteristics including the amount of plaque burden the type of plaque composition and the presence of high-risk features All of which are known to be associated with major adverse cardiovascular events MACE Furthermore recent studies have shown that PCAT attenuation can predict MACE and cardiac mortality
The PCAT-DM study is a post-hoc analysis from the CARPE-DM study NCT03016910 The goal of this prospective study is to investigate if PCAT attenuation andor PCAT changes are associated with high-risk plaque features plaque composition and burden Furthermore we want to investigate if PCAT attenuation andor PCAT changes can predict development of MACE in a follow-up period of 7 years
Setting and study population
A single-center prospective observational study at Odense University Hospital Svendborg Denmark The study enrollment was initiated in March 2016 and ended in September 2017 The study population consists of cardiovascular asymptomatic participants with type 2 diabetes mellitus
Examinations
A total of 314 patients were examined with a CCTA scan at baseline and after 12 months The following examinations were conducted at baseline
CCTA scan
CAC-score
Blood pressure and pulse frequency
Height weight waist to hip-ratio
Blood samples and urin samples
Medical history After 12 months all of the above examinations was repeated
Journal audits will be performed in the period from September 2024 to January 2025 to examine the number of clinical events according to the primary and secondary outcomes
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