Ignite Creation Date:
2024-05-05 @ 10:14 PM
Last Modification Date:
2024-10-26 @ 10:16 AM
Study NCT ID:
NCT01067456
Status:
COMPLETED
Last Update Posted:
2017-12-22
First Post:
2010-02-10
Brief Title:
Comprehensive Cardiothoracic Dual Source CT for the Early Triage of Patients With Acute Chest Pain
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Diagnostic Value of Comprehensive Cardiothoracic Dual Source CT for the Early Triage of Patients With Undifferentiated Acute Chest Pain
Status:
COMPLETED
Status Verified Date:
2017-11
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:
CAPTURE
Brief Summary:
The purpose of this research is to determine the efficiency of a single dual source computed tomography CT-DSCT protocol to establish or exclude acute coronary syndrome ACS pulmonary embolism PE or aortic dissection AD as compared to the individual protocols Endpoints aim to compare the rate of emergency department ED discharge length of hospital stay the diagnostic imaging test utilization and the costs between the comprehensive and the standard protocol strategy in patients with undifferentiated chest discomfort or shortness of breath with a component of chest discomfort
Detailed Description:
Undifferentiated chest pain is one of the most common complaints in the acute care setting accounting for over five million emergency department ED visits in the US each year Moreover early and accurate triage of these patients remains difficult as neither the chest pain history a single set of biochemical markers for myocardial necrosis or the initial 12-lead electrocardiogram ECG alone or in combination identify a group of patients that can be safely discharged without further diagnostic testing As a result patients presenting to the ED with undifferentiated chest pain are often evaluated with multiple examinations to exclude the presence of myocardial infarction MIpulmonary embolism PE andor aortic dissection AD
While contrast-enhanced spiral computed tomography angiography CTA has become a standard procedure in the evaluation of the presence of PE and AD it was only within the past few years that noninvasive detection of coronary artery stenosis with CTA has become feasible Coronary CTA has been proven to be an effective tool to rule out CAD with reported sensitivities of 93-99 and specificities of 95-97 as compared to invasive coronary angiography
Recent data from our Rule Out Myocardial Infarction by Computer Assisted Tomography ROMICAT study indicates that coronary CTA accurately rules out acute coronary syndrome ACS in patients with acute chest pain and therefore may enhance the diagnostic work up of chest pain patients in the ED Moreover this study demonstrated the distribution of several CT-angiographic patterns of CAD which may change management of subjects with inconclusive initial ED evaluation admitted to the hospital For example CTA demonstrated the absence of any CAD in 50 of the patients None of the subjects without any CAD on CTA developed unstable angina or had an MI during index hospitalization Furthermore none of these patients had any MACE over the next six months confirming previous observations in ACS patients These data suggest that 50 of hospital admissions could be saved Another recent study our group has demonstrated that an individually tailored ECG-gated CT protocol with a single contrast injection permits simultaneous visualization of the coronary arteries thoracic aorta and pulmonary arteries with excellent image quality
The very recent introduction of dual source CT DSCT technology offers a two-fold improvement in temporal resolution as compared to the standard 64-slice CTA that was used for these studies 83ms vs 165ms respectively This significant improvement in temporal resolution allows for the acquisition of diagnostic images with higher and irregular heart rates precluding the need for intravenous beta blockade Given the improved temporal resolution and faster acquisition time the amount of radiation exposure can be markedly reduced in many patients
With the need to improve triage of patients with undifferentiated chest pain and the advantages offered by DSCT technology several observational case series have suggested the feasibility of a comprehensive thoracic DSCT CT-DSCT to simultaneously evaluate the coronary arteries thoracic aorta and pulmonary arteries Whether this will result in an improvement of patient management and test utilization remains unclear as compared to a standard ED evaluation protocol needs to be evaluated
Thus the purpose of this research is to determine the efficiency of a single CT-DSCT protocol to establish or exclude MI PE or AD as compared to the individual protocols Endpoints aim to compare the rate of ED discharge length of hospital stay the diagnostic imaging test utilization and the costs between the comprehensive and the standard protocol strategy in patients with undifferentiated chest discomfort or shortness of breath with a component of chest discomfort
While contrast-enhanced spiral computed tomography angiography CTA has become a standard procedure in the evaluation of the presence of PE and AD it was only within the past few years that noninvasive detection of coronary artery stenosis with CTA has become feasible Coronary CTA has been proven to be an effective tool to rule out CAD with reported sensitivities of 93-99 and specificities of 95-97 as compared to invasive coronary angiography
Recent data from our Rule Out Myocardial Infarction by Computer Assisted Tomography ROMICAT study indicates that coronary CTA accurately rules out acute coronary syndrome ACS in patients with acute chest pain and therefore may enhance the diagnostic work up of chest pain patients in the ED Moreover this study demonstrated the distribution of several CT-angiographic patterns of CAD which may change management of subjects with inconclusive initial ED evaluation admitted to the hospital For example CTA demonstrated the absence of any CAD in 50 of the patients None of the subjects without any CAD on CTA developed unstable angina or had an MI during index hospitalization Furthermore none of these patients had any MACE over the next six months confirming previous observations in ACS patients These data suggest that 50 of hospital admissions could be saved Another recent study our group has demonstrated that an individually tailored ECG-gated CT protocol with a single contrast injection permits simultaneous visualization of the coronary arteries thoracic aorta and pulmonary arteries with excellent image quality
The very recent introduction of dual source CT DSCT technology offers a two-fold improvement in temporal resolution as compared to the standard 64-slice CTA that was used for these studies 83ms vs 165ms respectively This significant improvement in temporal resolution allows for the acquisition of diagnostic images with higher and irregular heart rates precluding the need for intravenous beta blockade Given the improved temporal resolution and faster acquisition time the amount of radiation exposure can be markedly reduced in many patients
With the need to improve triage of patients with undifferentiated chest pain and the advantages offered by DSCT technology several observational case series have suggested the feasibility of a comprehensive thoracic DSCT CT-DSCT to simultaneously evaluate the coronary arteries thoracic aorta and pulmonary arteries Whether this will result in an improvement of patient management and test utilization remains unclear as compared to a standard ED evaluation protocol needs to be evaluated
Thus the purpose of this research is to determine the efficiency of a single CT-DSCT protocol to establish or exclude MI PE or AD as compared to the individual protocols Endpoints aim to compare the rate of ED discharge length of hospital stay the diagnostic imaging test utilization and the costs between the comprehensive and the standard protocol strategy in patients with undifferentiated chest discomfort or shortness of breath with a component of chest discomfort
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