Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00431860
Status:
UNKNOWN
Last Update Posted:
2007-05-03
First Post:
2007-02-05
Brief Title:
Subclinical COronary Atheroscleorosis Updated With Coronary cT Angiography SCOUT Study
Sponsor:
Seoul National University Bundang Hospital
Organization:
Seoul National University Bundang Hospital
Study Overview
Official Title:
Subclinical COronary Atheroscleorosis Updated With Coronary cT Angiography SCOUT Study
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
RECRUITING
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 purpose of this study is to validate the usefulness of 64-slice multi-detecter computeted tomography as a screening tool in asymptomatic population
Detailed Description:
A large proportion of patients with sudden cardiac death or nonfatal myocardial infarction MI had no prior symptom which emphasizes the importance of early detection and treatment of the underlying subclinical coronary atherosclerosis before they happen However there are no powerful screening methods to detect subclinical coronary atherosclerosis until recently Traditional CAD risk factors treadmill exercise test and EBCT are known to have limited power to detect subclinical coronary atherosclerosis and predict future cardiac events
Coronary CT angiography CTA depicting detailed coronary artery anatomy in a noninvasive fashion would seem to be already one of the mainstays of diagnostic procedure in symptomatic population Instead of the probability of significant stenosis CTA could provide information about the location burden and characteristics of atherosclerotic plaque per se which might give additional insight to stratify the risk of future cardiac events and therapy
In this study we will evaluate the prevalence and characteristics of subclinical coronary atherosclerosis on CTA and its impact on the management in asymptomatic population And then we will develop standardized protocol for the management of subclinical coronary atherosclerosis and follow for adverse cardiac events
In phase I study we will enroll subjects who had undergone CTA and analyze the characteristics of plaques on CTA Also we will evaluate the impact of CTA by comparing the performance of secondary test with those who had not undergone CTA evaluation
In phase II study we will recruit subjects who had significant coronary stenosis on CTA If the patients had significant stenosis they will undergo coronary angiography to confirm the severity of stenosis If they had coronary artery stenosis more than 75 they will receive percutaneous coronary intervention with drug-eluting stent DES If they had intermediate lesion their treatment option will be judged by the results of fractional flow reserve test If they had coronary lesion less than 50 they will be treated only by medication
When the patients are eligible for study investigators will give information about the study and obtain written consent The presence of chest pain symptom will be screened with Rose questionnaire Medical history and physical examination will be performed and baseline laboratory work-up will be performed
Following above treatment guidelines all patients will be followed for adverse cardiac events for 5 years
Coronary CT angiography CTA depicting detailed coronary artery anatomy in a noninvasive fashion would seem to be already one of the mainstays of diagnostic procedure in symptomatic population Instead of the probability of significant stenosis CTA could provide information about the location burden and characteristics of atherosclerotic plaque per se which might give additional insight to stratify the risk of future cardiac events and therapy
In this study we will evaluate the prevalence and characteristics of subclinical coronary atherosclerosis on CTA and its impact on the management in asymptomatic population And then we will develop standardized protocol for the management of subclinical coronary atherosclerosis and follow for adverse cardiac events
In phase I study we will enroll subjects who had undergone CTA and analyze the characteristics of plaques on CTA Also we will evaluate the impact of CTA by comparing the performance of secondary test with those who had not undergone CTA evaluation
In phase II study we will recruit subjects who had significant coronary stenosis on CTA If the patients had significant stenosis they will undergo coronary angiography to confirm the severity of stenosis If they had coronary artery stenosis more than 75 they will receive percutaneous coronary intervention with drug-eluting stent DES If they had intermediate lesion their treatment option will be judged by the results of fractional flow reserve test If they had coronary lesion less than 50 they will be treated only by medication
When the patients are eligible for study investigators will give information about the study and obtain written consent The presence of chest pain symptom will be screened with Rose questionnaire Medical history and physical examination will be performed and baseline laboratory work-up will be performed
Following above treatment guidelines all patients will be followed for adverse cardiac events for 5 years
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