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NCT00321399 · ClinicalTrials.gov registry record
Study of Perfusion and Anatomy's Role in Coronary Artery (CAD)
A clinical trial, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- 3,019
- Enrollment target
NCT00321399 is a clinical trial that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 3,019 participants.
The verdict
NCT00321399 has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- 3,019 participants
- Enrollment target
Study 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 (PET+CTA and SPECT+CTA) 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 in
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,019 participants |
| Start Date | 2006-06 |
| Est. Completion | 2014-07 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00321399
The ClinicalTrials.gov registry entry for NCT00321399 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 3,019 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00321399 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00321399 about?
NCT00321399 is a clinical study titled "Study of Perfusion and Anatomy's Role in Coronary Artery (CAD)". 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 ...
What is the current status of trial NCT00321399?
This trial is currently completed. The enrollment target is 3,019 participants. The study started on 2006-06. Estimated completion is 2014-07.
Who is sponsoring clinical trial NCT00321399?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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