Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321399
Status:
COMPLETED
Last Update Posted:
2014-07-16
First Post:
2006-05-01
Brief Title:
Study of Perfusion and Anatomys Role in Coronary Artery CAD
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
SPARC Including Its Pilot CT Angiographic Study is a Prospective Open-label Multicenter Sequentially Sampled Observational Registry to Define the Clinical Value of Stress Perfusion Stress SPECT Stress PET Noninvasive Angiography CTA and Combined Perfusion-anatomy PETCT Studies in Patients With Known or Suspected CAD With Respect to Post-test Resource Utilization and Prediction of Cardiac Death and Non-fatal Myocardial Infarction
Status:
COMPLETED
Status Verified Date:
2014-07
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:
SPARC
Brief Summary:
Three main clinical outcomes will be assessed
1 Post-test resource utilization as assessed by referral rate to catheterization within 90-days of the index study
2 Incremental prognostic value and risk stratification for predicting cardiac death and myocardial infarction
3 Cost-effectiveness
To this end SPARC is organized with two distinct specific objectives with important differences in patient population and endpoints
Specific Aim 1 To evaluate the impact of stress perfusion imaging with SPECT or PET CT Angiography and hybrid PET-CT on post-test resource utilization
The primary endpoint of specific aim 1 is to compare the impact of combined myocardial perfusion-coronary anatomy data to that of perfusion only stress SPECT stress cardiac PET without CTA and anatomy only CTA alone on post-test resource utilization as measured by referral to cardiac catheterization within 90 days of index noninvasive testing in patients without CAD
Secondary endpoints
1 to compare the diagnostic accuracy for detection of epicardial CAD of stress PET and hybrid PET-CT stress SPECT and CTA as defined by coronary angiography
2 to compare the referral rate to revascularization within 90 days of cardiac catheterization
Specific Aim 2 To compare the incremental prognostic value and risk stratification of stress perfusion imaging with SPECT or PET CT coronary angiography and combined perfusion-anatomy imaging approaches
The primary endpoint of specific aim 2 is to compare the incremental value of stress perfusion only stress PET and stress SPECT coronary anatomy only CTA data and combined perfusion-anatomy studies PETCTA and SPECTCTA over clinical historical and stress test data for the prediction of cardiac death and nonfatal myocardial infarction
Secondary endpoints
1 to compare the incremental value of these noninvasive imaging approaches over clinical historical and stress test data for the prediction of a composite endpoint including cardiac death nonfatal myocardial infarction late 6 month from index study referral to revascularization or late 6 month from index study hospitalization for chest pain or heart failure
2 to compare the incremental value of these noninvasive imaging approaches over clinical historical and stress test data for the prediction of all cause mortality In addition the ability of these modalities -together and separately- to risk stratify patients is a primary goal of specific aim 2
1 Post-test resource utilization as assessed by referral rate to catheterization within 90-days of the index study
2 Incremental prognostic value and risk stratification for predicting cardiac death and myocardial infarction
3 Cost-effectiveness
To this end SPARC is organized with two distinct specific objectives with important differences in patient population and endpoints
Specific Aim 1 To evaluate the impact of stress perfusion imaging with SPECT or PET CT Angiography and hybrid PET-CT on post-test resource utilization
The primary endpoint of specific aim 1 is to compare the impact of combined myocardial perfusion-coronary anatomy data to that of perfusion only stress SPECT stress cardiac PET without CTA and anatomy only CTA alone on post-test resource utilization as measured by referral to cardiac catheterization within 90 days of index noninvasive testing in patients without CAD
Secondary endpoints
1 to compare the diagnostic accuracy for detection of epicardial CAD of stress PET and hybrid PET-CT stress SPECT and CTA as defined by coronary angiography
2 to compare the referral rate to revascularization within 90 days of cardiac catheterization
Specific Aim 2 To compare the incremental prognostic value and risk stratification of stress perfusion imaging with SPECT or PET CT coronary angiography and combined perfusion-anatomy imaging approaches
The primary endpoint of specific aim 2 is to compare the incremental value of stress perfusion only stress PET and stress SPECT coronary anatomy only CTA data and combined perfusion-anatomy studies PETCTA and SPECTCTA over clinical historical and stress test data for the prediction of cardiac death and nonfatal myocardial infarction
Secondary endpoints
1 to compare the incremental value of these noninvasive imaging approaches over clinical historical and stress test data for the prediction of a composite endpoint including cardiac death nonfatal myocardial infarction late 6 month from index study referral to revascularization or late 6 month from index study hospitalization for chest pain or heart failure
2 to compare the incremental value of these noninvasive imaging approaches over clinical historical and stress test data for the prediction of all cause mortality In addition the ability of these modalities -together and separately- to risk stratify patients is a primary goal of specific aim 2
Detailed Description:
None
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