AMERICAN COLLEGE OF RADIOLOGY, THE
Coronary CT angiography (CCTA) represents a potentially disruptive technology in terms of its impact on the clinical evaluation and management of coronary artery disease (CAD). This was highlighted by its inclusion in the Consensus Report on Initial National Priorities for Comparative Effectiveness Research (CER) issued by the Institute of Medicine (IOM). Specifically, the report recommends: Compare the effectiveness of computed tomography (CT) angiography and conventional angiography in assessing coronary stenosis in patients at moderate pretest risk of coronary artery disease. An additional IOM aim stated in the Consensus Report, most likely in response to the results of the COURAGE trial, recommends research comparing the effectiveness of aggressive medical management and percutaneous coronary interventions in treating stable coronary disease for patients of different ages and with different comorbidities. The results of the COURAGE trial suggest that patients with stable angina diagnosed with CAD and initially treated with optimal medical therapy (OMT) alone have no difference in outcomes in comparison to individuals treated with both OMT and percutaneous coronary intervention (PCI). CCTA, by explicitly identifying patients with potentially significant left main disease, can safely select patients for OMT without requiring invasive coronary angiography. This is not the case for the more traditional single photon emission tomography myocardial perfusion imaging (SPECT MPI) where patients with a positive test for CAD will require invasive angiography to identify potential left main disease prior to the safe initiation of OMT. We propose the Randomized Evaluation of Patients with Stable Angina Comparing Utilization of Noninvasive Examinations (RESCUE), a multi-center randomized, controlled trial. This study builds on the results of the COURAGE trial by comparing CCTA and SPECT-MPI integrated into a care paradigm featuring initial treatment with optimized medical therapy for patients diagnosed with CAD without significant disease in the left main coronary artery. Patients will be followed for a composite endpoint of major adverse cardiac events (MACE) and cross-over to revascularization over a 12-24 month period. Several comparative effectiveness analyses will be performed. We hypothesize that the CCTA arm will be associated with no increase in major coronary events (MACE) or revascularization, decreased cost and increased cost-effectiveness in comparison to SPECT-MPI. Findings are expected to result in validation of an evolving new standard of care for patients with stable angina that takes advantage of CCTA to more cost effectively drive appropriate care.
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| AWARD OVERVIEW |
| Award Number |
1R01HS01940301 |
Funding Agency |
Department of Health and Human Services |
| Total Award Amount |
$9,666,726 |
Project Location - City |
Philadelphia |
| Award Date |
09/28/2010 |
Project Location - State |
PA |
| Project Status |
Less Than 50% Completed |
Project Location - Zip |
19103-3638
|
| Jobs Reported |
12.18 |
Congressional District |
02 |
| Project Location - Country |
US |
|
|
Recipient Information
(Grants)
| Recipient Information (Grants) |
|
Recipient Name
|
AMERICAN COLLEGE OF RADIOLOGY, THE |
| Recipient DUNS Number |
062485800
|
| Recipient Address |
1891 PRESTON WHITE DR STE 1 |
| Recipient City |
RESTON |
| Recipient State |
Virginia |
| Recipient Zip |
20191-5431 |
| Recipient Congressional District |
11 |
| Recipient Country |
USA |
Required to Report Top 5
Highly Compensated Officials |
No |
Projects and Jobs Information
| Projects and Jobs Information |
| Project Title |
RESCUE: Randomized Evaluation of Patients with Stable Angina Comparing Utilization of |
| Project Status |
Less Than 50% Completed |
| Final Project Report Submitted |
No |
| Project Activities Description |
People/Families of People with Health Conditions |
| Quarterly Activities/Project Description |
RESCUE Progress Report (Jan-March, 2013)
Specific Aims
The primary endpoint of the study is a combined endpoint of occurrence of MACE, comprising cardiac-related death or acute MI, and revascularization (see Appendix IV for definitions). We will calculate differences in the combined MACE/revascularization endpoint between the CCTA and SPECT MPI/ICA arms.
Studies and Results
Site Selection and Accrual
As of March 31, 2012, forty two sites had accrued at least one case on the trial. Participating sites may be reviewed at:
http://www.acrin.org/PROTOCOLSUMMARYTABLE/ACRIN4701RESCUE/4701ParticipatingSites.aspx
Study accrual totaled 970 subjects as of March 31. The trial has six months of ARRA/AHRQ funding remaining and it is anticipated that 1300 subjects will be accrued by September. Private funding is being sought to allow full 12 month follow up on the 1300 subjects.
Follow Up
As of March 31, 2013, 90% of the follow up forms due had been submitted. Follow up with the subject is by telephone at six month time intervals.
Outcomes and Quality of Life Component
Abstraction data forms has been developed, programmed, and tested. Medical charts have been procured. Testing of the reporting database for abstractors as well as the case report forms continues with the pilot chart abstraction re-scheduled to April. The 12 month follow up for the quality of life sub-study is in progress.
Plans
1. Accelerate enrollment at activated sites, particularly those able to enroll > 50 /year.
2 Continue discussions with private funding to enable the trial to continue full 12 month follow up on all participants..
3. Continue 6 and 12 month follow up of subjects.
4. Conduct pilot medical chart abstraction and continue 12 month quality of life follow up.
|
| Jobs Created |
12.18 |
| Description of Jobs Created |
Project Manager the project manager for RESCUE is responsible for overall coordination of the clinical trial team and oversees all administrative aspects of the project. Efforts to date have included providing leadership to the overall ACRIN project team, communicating with possible additional sources of funding, negotiation of contracts, and recruiting potential participating clinical sites.
Data Management Research Associates the Research Associates for RESCUE are responsible for the clinical data collection and management of data. They interact closely with the statistical center to ensure that endpoints are fully captured in the data forms. Research Associates are responsible for responding to sites questions regarding eligibility, form completion, and protocol deviations. In addition, research associates are responsible, with data support, for procuring redacting, and reviewing all medical records to be used in the adjudication and abstraction process.
Imaging Analysts the imaging analysts are responsible for developing Quality Control mechanisms for reviewing the coronary CT angiograms and SPECT images that are submitted via the web. They review all test images that are submitted to ACRIN as a requirement for approving a site for activation.
Imaging Analyst Assistant this person is responsible for retrieving and matching paper image transmittal forms to the images transmitted via the web and receipting images.
Site Recruitment Specialist - collaborates with participating sites to assist in completion of regulatory and ACRIN application documents through site activation. Actively recruits sites to engage in the trial. Serves as go to informational specialist about the trial.
Monitor the monitor is responsible for site initiation teleconferences and trial monitoring.
MIS The IT programmers are responsible for programming case report forms to enable web entry. Recent efforts involve programming the web entry of the medical abstraction forms and testing the database.
Data Support -The data support clerk is responsible for keying the hardcopy paper forms (quality control of images and over reads) into to the database and scanning medical records received.
Subcontract Personnel: PI, Co-PIs, Statisticians, Data Coord, Programmer, Site PIs, a nuclear tech and clinical research coordinator.
|
Purchaser Information
(Grants)
| Purchaser Information |
| Contracting Office ID |
Not Reported |
| Contracting Office Name |
Not Available |
| Contracting Office Region |
Not Available |
| TAS Major Program |
75-1701 |
| Award Information |
| Award Date |
09/28/2010 |
| Award Number |
1R01HS01940301 |
| Order Number |
|
| Award Type |
Grants |
| Funding Agency ID |
75 |
| Funding Agency Name |
Department of Health and Human Services |
| Funding Office Name |
Not Available |
| Awarding Agency ID |
75 |
| Awarding Agency Name |
Department of Health and Human Services |
| Amount of Award |
$9,666,726 |
| Funds Invoiced/Received |
$5,398,191 |
| Expenditure Amount |
$5,398,191 |
| Infrastructure Expenditure Amount |
$0 |
| Infrastructure Purpose and Rationale |
Not Reported |
| Infrastructure Point of Contact Name |
Not Reported |
| Infrastructure Point of Contact Email |
Not Reported |
| Infrastructure Point of Contact Phone |
Not Reported |
| Infrastructure Point of Contact Address |
Not Reported |
| Infrastructure Point of Contact City |
Not Reported |
| Infrastructure Point of Contact State |
Not Reported |
| Infrastructure Point of Contact Zip |
Not Reported |
Product or Service Information
(Grants)
| Product or Service Information |
| Primary Activity Code |
+H10 |
| Activity Description |
People/Families of People with Health Conditions |
| Sub-Awards Information |
| Sub-awards to Organizations |
6 |
| Sub-award Amounts to Organizations |
$2,404,468 |
| Sub-Awards to Individuals |
0 |
| Sub-Award Amounts to Individuals |
$0 |
| Number of Sub-awards less than $25,000/award |
1 |
| Amount of Sub-awards less than $25,000/award |
$2,536 |
| Number of payments to vendors greater than $25,000 |
1 |
| Total Amount of payments to vendors greater than $25,000/award |
$59,730 |
| Number of payments to vendors less than $25,000/award |
0 |
| Total Amount of payments to vendors less than $25,000/award |
$0 |
Sub-award ACRIN 4701 - BROWN UNIVERSITY IN PROVIDENCE IN STATE OF RI AND PROVIDENCE PLANTATIONS
| Sub-Award Amount |
$1,303,030 |
| Sub-Award Date |
04/12/2011 |
| Sub-Awards Disbursed |
$877,540.99 |
| Project Location - City |
Providence |
| Project Location - State |
RI |
| Project Location - Zip Code |
02912-9002 |
| Project Location - Congressional District |
01 |
| Sub-Recipient DUNS Number |
001785542
|
| Sub-Recipient Address |
1 PROSPECT ST |
| Sub-Recipient City |
PROVIDENCE |
| Sub-Recipient State |
Rhode Island |
| Sub-Recipient Zip Code |
02912-9079 |
| Sub-Recipient Congressional District |
01 |
Required To Report Top 5
Highly Compensated Officials |
No |
Sub-award Stillman - EMORY UNIVERSITY
| Sub-Award Amount |
$291,342 |
| Sub-Award Date |
03/08/2011 |
| Sub-Awards Disbursed |
$218,902.77 |
| Project Location - City |
Atlanta |
| Project Location - State |
GA |
| Project Location - Zip Code |
30322-1059 |
| Project Location - Congressional District |
05 |
| Sub-Recipient DUNS Number |
066469933
|
| Sub-Recipient Address |
201 DOWMAN DR |
| Sub-Recipient City |
ATLANTA |
| Sub-Recipient State |
Georgia |
| Sub-Recipient Zip Code |
30322-1018 |
| Sub-Recipient Congressional District |
05 |
Required To Report Top 5
Highly Compensated Officials |
No |
Sub-award 1093 - JOHNS HOPKINS UNIVERSITY, THE
| Sub-Award Amount |
$67,648 |
| Sub-Award Date |
03/16/2012 |
| Sub-Awards Disbursed |
$32,977.08 |
| Project Location - City |
Baltimore |
| Project Location - State |
MD |
| Project Location - Zip Code |
21205-1832 |
| Project Location - Congressional District |
07 |
| Sub-Recipient DUNS Number |
001910777
|
| Sub-Recipient Address |
3400 N CHARLES ST W400 WYMAN PARK BLDG |
| Sub-Recipient City |
BALTIMORE |
| Sub-Recipient State |
Maryland |
| Sub-Recipient Zip Code |
21218-2680 |
| Sub-Recipient Congressional District |
07 |
Required To Report Top 5
Highly Compensated Officials |
No |
Sub-award MGH 4485 - MASSACHUSETTS GENERAL HOSPITAL, THE
| Sub-Award Amount |
$572,448 |
| Sub-Award Date |
03/01/2011 |
| Sub-Awards Disbursed |
$162,166.30 |
| Project Location - City |
Boston |
| Project Location - State |
MA |
| Project Location - Zip Code |
02114-2621 |
| Project Location - Congressional District |
08 |
| Sub-Recipient DUNS Number |
073130411
|
| Sub-Recipient Address |
55 FRUIT ST |
| Sub-Recipient City |
BOSTON |
| Sub-Recipient State |
Massachusetts |
| Sub-Recipient Zip Code |
02114-2621 |
| Sub-Recipient Congressional District |
08 |
Required To Report Top 5
Highly Compensated Officials |
No |
Sub-award 2501036612244000001 - TUFTS MEDICAL CENTER, INC.
| Sub-Award Amount |
$95,252 |
| Sub-Award Date |
03/17/2011 |
| Sub-Awards Disbursed |
$86,920.06 |
| Project Location - City |
Boston |
| Project Location - State |
MA |
| Project Location - Zip Code |
02111-1526 |
| Project Location - Congressional District |
07 |
| Sub-Recipient DUNS Number |
079532263
|
| Sub-Recipient Address |
800 WASHINGTON ST |
| Sub-Recipient City |
BOSTON |
| Sub-Recipient State |
Massachusetts |
| Sub-Recipient Zip Code |
02111-1526 |
| Sub-Recipient Congressional District |
07 |
Required To Report Top 5
Highly Compensated Officials |
No |
Sub-award 66103003272 - WASHINGTON UNIVERSITY, THE
| Sub-Award Amount |
$74,748 |
| Sub-Award Date |
05/01/2011 |
| Sub-Awards Disbursed |
$61,741.76 |
| Project Location - City |
St. Louis |
| Project Location - State |
MO |
| Project Location - Zip Code |
63110-1010 |
| Project Location - Congressional District |
01 |
| Sub-Recipient DUNS Number |
068552207
|
| Sub-Recipient Address |
1 BROOKINGS DR |
| Sub-Recipient City |
SAINT LOUIS |
| Sub-Recipient State |
Missouri |
| Sub-Recipient Zip Code |
63130-4862 |
| Sub-Recipient Congressional District |
01 |
Required To Report Top 5
Highly Compensated Officials |
No |
Care Communication - Award Number 1R01HS01940301 - Care Communication
| Award Number |
1R01HS01940301 |
| Sub-Award Number |
N/A |
| Vendor DUNS Number |
Not reported |
| Vendor HQ Zip Code + 4 |
60606-1214 |
| Vendor Name |
Care Communication |
| Product and Service Description |
Patient chart abstraction services |
| Payment Amount |
$59,730 |
| Location Information |
| Latitude, Longitude |
39º 57' 11",
-75º 10' 13" |
| Congressional District |
02 |
| Address 1 |
1818 Market Street |
| Address 2 |
Suite 1600 |
| City |
Philadelphia |
| County |
Philadelphia |
| State |
PA |
| Zip |
19103-3638 |
|
 |