Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482651
Status:
COMPLETED
Last Update Posted:
2012-01-23
First Post:
2007-06-04
Brief Title:
Imaging of Vulnerable Plaques in Coronary Artery Disease by Multidetector Computed Tomography
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Imaging of Vulnerable Plaques in Coronary Artery Disease by Multidetector Computed Tomography
Status:
COMPLETED
Status Verified Date:
2012-01
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:
Atherosclerosis is a chronic and multifocal immunoinflammatory fibroproliferative disease of medium-sized and large arteries driven by lipid Atherosclerosis is rarely fatal unless thrombosis supervene causing an acute coronary syndrome Therefore for event-free survival the vital question is not why atherosclerosis develops but rather why atherosclerosis after years after indolent growth suddenly becomes complicated with luminal thrombosis
The great majority of coronary plaques will remain quiescent at least from a clinical point of view
Acute coronary syndrome is primarily precipitated by a ruptured plaque The precipitating factor or condition may be found outside rather than inside the plaque
The challenge is to find the plaques destined for the next thrombus-mediated heart attacks treat and thus avoid the heart attacks Identification of vulnerable plaques has become a key issue The natural history of individual plaques risk of thrombosis is unknown and needs to be established
Multidetector computed tomography MDCT can provide angiography and imaging of the vessel wall detection quantification and characterization of plaques
The intention of this project is to evaluate the accuracy of coronary MDCT in identifying and differentiating the morphology of coronary atherosclerotic plaques
The great majority of coronary plaques will remain quiescent at least from a clinical point of view
Acute coronary syndrome is primarily precipitated by a ruptured plaque The precipitating factor or condition may be found outside rather than inside the plaque
The challenge is to find the plaques destined for the next thrombus-mediated heart attacks treat and thus avoid the heart attacks Identification of vulnerable plaques has become a key issue The natural history of individual plaques risk of thrombosis is unknown and needs to be established
Multidetector computed tomography MDCT can provide angiography and imaging of the vessel wall detection quantification and characterization of plaques
The intention of this project is to evaluate the accuracy of coronary MDCT in identifying and differentiating the morphology of coronary atherosclerotic plaques
Detailed Description:
Atherosclerosis without thrombosis is rarely fatal It is the acute thrombotic complications which account for disability and death Therefore for event-free survival the question is not why atherosclerosis develops but rather why atherosclerosis after years after indolent growth suddenly becomes complicated with luminal thrombosis
Post-mortem and clinical observations indicate that patients with acute coronary syndromes often have many ruptured andor active plaques in their coronary arteries
The challenge is to find the plaques destined for the next thrombus-mediated heart attacks treat and thus avoid the heart attacks Identification of vulnerable plaques have become a key issue The natural history of individual plaques risk of thrombosis is unknown and needs to be established Multidetector computed tomography MDCT can provide angiography and imaging of the vessel wall
Hypothesis
It is by CT-scanning possible to 1a identify and differentiate the morphology of coronary atherosclerotic plaques
1b identify vulnerable plaques
Materials and methods
1 Development of an MDCT scan protocol for accurate assessment of coronary artery plaque composition by ex vivo examination of human coronary arteries from the Institute of Forensic Medicine University of Aarhus Scan protocols parameters and intravascular contrast material will be varied to optimize accurate assessment of coronary plaque composition MDCT will be compared to histopathology
2 A cross-sectional study with clinical application of the efficiency parameters defined in sub-study 1 Forty consecutive patients with non ST-elevation myocardial infarctionunstable angina and 80 consecutive patients with stable angina will be recruited and investigated with MDCT followed by CAG with IVUSvirtual histology
3 A prospective longitudinal study After a period of 12 months all patients from sub-study 2 will be re-investigated
4 Before the cross-sectional study a small pilot-study will be performed Ten patients with non ST-elevation myocardial infarctionunstable angina will undergo MDCT and CAG with IVUSvirtual histology These patients will after one months undergo another MDCT This is done to make sure that it is possible to perform the planned longitudinal study
Research plan
1 Development of an MDCT scan protocol for accurate assessment of coronary artery plaque composition
2 Clinical application of the MDCT scan protocol for in vivo differentiation of coronary artery plaque morphology Morphologic findings will be categorized and compared with IVUSvirtual histology for confirmation
3 Re-evaluation of plaque density and morphology one year after inclusion by a second in vivo contrast-enhanced MDCT-scanning to define which morphological plaque categories are at risk of progression
Post-mortem and clinical observations indicate that patients with acute coronary syndromes often have many ruptured andor active plaques in their coronary arteries
The challenge is to find the plaques destined for the next thrombus-mediated heart attacks treat and thus avoid the heart attacks Identification of vulnerable plaques have become a key issue The natural history of individual plaques risk of thrombosis is unknown and needs to be established Multidetector computed tomography MDCT can provide angiography and imaging of the vessel wall
Hypothesis
It is by CT-scanning possible to 1a identify and differentiate the morphology of coronary atherosclerotic plaques
1b identify vulnerable plaques
Materials and methods
1 Development of an MDCT scan protocol for accurate assessment of coronary artery plaque composition by ex vivo examination of human coronary arteries from the Institute of Forensic Medicine University of Aarhus Scan protocols parameters and intravascular contrast material will be varied to optimize accurate assessment of coronary plaque composition MDCT will be compared to histopathology
2 A cross-sectional study with clinical application of the efficiency parameters defined in sub-study 1 Forty consecutive patients with non ST-elevation myocardial infarctionunstable angina and 80 consecutive patients with stable angina will be recruited and investigated with MDCT followed by CAG with IVUSvirtual histology
3 A prospective longitudinal study After a period of 12 months all patients from sub-study 2 will be re-investigated
4 Before the cross-sectional study a small pilot-study will be performed Ten patients with non ST-elevation myocardial infarctionunstable angina will undergo MDCT and CAG with IVUSvirtual histology These patients will after one months undergo another MDCT This is done to make sure that it is possible to perform the planned longitudinal study
Research plan
1 Development of an MDCT scan protocol for accurate assessment of coronary artery plaque composition
2 Clinical application of the MDCT scan protocol for in vivo differentiation of coronary artery plaque morphology Morphologic findings will be categorized and compared with IVUSvirtual histology for confirmation
3 Re-evaluation of plaque density and morphology one year after inclusion by a second in vivo contrast-enhanced MDCT-scanning to define which morphological plaque categories are at risk of progression
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