Ignite Creation Date:
2024-05-05 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00539604
Status:
COMPLETED
Last Update Posted:
2007-10-04
First Post:
2007-10-03
Brief Title:
Non Invasive Multicenter Italian Study for Coronary Artery Disease
Sponsor:
Società Italiana di Radiologia Medica
Organization:
Società Italiana di Radiologia Medica
Study Overview
Official Title:
Phase IV Multicenter Intra-Individually Controlled Comparison Study to Evaluate the Negative Predictive Value of 16-64 Slice MDCT Imaging in Patients Scheduled for Coronary Angiography
Status:
COMPLETED
Status Verified Date:
2006-11
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:
To determine if 16-64 slice multidetector CT MDCT can replace the invasive procedure in patients scheduled for coronary angiography in order to exclude the presence of CAD
Detailed Description:
Because coronary artery disease CAD is the most frequent cause of death in industrialized nations and its onset is currently unpredictable there is a need for new methods of screening apparently healthy individuals to identify those at increased risk
Several imaging techniques are in use to visualize coronary arteries These include both invasive procedure as x-ray coronary angiography and those non invasive like computed tomography CT and magnetic resonance imaging MRI Among these imaging modalities selective cardiac catheterization and x-ray angiography is the current gold standard for visualization of coronaries and detection of their stenoses providing for optimal spatial resolution a general road map of the coronary tree for interventions The replacement of even a fraction of these procedures with non-invasive modalities would constitute an important advance in the care of patients with suspected coronary artery disease Preliminary results reported in literature addressing the study of coronary arteries by multidetector-CT MDCT appear to be interesting Several studies have been performed firstly using Electron beam CT EBCTEBCT provides high temporal resolution and enables quantitative assessment of the coronary artery calcium but because of limited spatial resolution as a result of limited z axis resolution it does not permit direct visualisation in multi-reformation of the whole coronary artery system
With the introduction of 4-row MDCT there have now been several studies aimed to compare the MDCT with a standard invasive angiography Data published for over 200 subjects from 4 studies demonstrated that patient compliance at breath-hold heart rate and rhythm are crucial limitation to this procedure In the Nieman and Achembach papers not all the coronary segments were assessable because of the limited temporal resolution of 4-slice MDCT With this machine it is mandatory to select patients carefully considering only those with baseline hearth rate 65 bpm also obtained by pre-treatment with β-blockers in order to slow hearth rate
Several imaging techniques are in use to visualize coronary arteries These include both invasive procedure as x-ray coronary angiography and those non invasive like computed tomography CT and magnetic resonance imaging MRI Among these imaging modalities selective cardiac catheterization and x-ray angiography is the current gold standard for visualization of coronaries and detection of their stenoses providing for optimal spatial resolution a general road map of the coronary tree for interventions The replacement of even a fraction of these procedures with non-invasive modalities would constitute an important advance in the care of patients with suspected coronary artery disease Preliminary results reported in literature addressing the study of coronary arteries by multidetector-CT MDCT appear to be interesting Several studies have been performed firstly using Electron beam CT EBCTEBCT provides high temporal resolution and enables quantitative assessment of the coronary artery calcium but because of limited spatial resolution as a result of limited z axis resolution it does not permit direct visualisation in multi-reformation of the whole coronary artery system
With the introduction of 4-row MDCT there have now been several studies aimed to compare the MDCT with a standard invasive angiography Data published for over 200 subjects from 4 studies demonstrated that patient compliance at breath-hold heart rate and rhythm are crucial limitation to this procedure In the Nieman and Achembach papers not all the coronary segments were assessable because of the limited temporal resolution of 4-slice MDCT With this machine it is mandatory to select patients carefully considering only those with baseline hearth rate 65 bpm also obtained by pre-treatment with β-blockers in order to slow hearth rate
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