Trial Outcomes & Findings for Half-Dose Radiopharmaceutical in Wide Beam Reconstruction (NCT NCT01499654)
NCT ID: NCT01499654
Last Updated: 2016-02-24
Results Overview
Left ventricular myocardium was divided into standardized 17-segments with 6 equiangular segments in the basal region, 6 equiangular segments in the mid region, 4 equiangular segments in the apical regions, and 1 region in the apex (Cerqueira MD, et al., J Nucl Cardiol 2002;9:240-5). Each segment was scored on a scale from 0 to 4 to indicate the severity of the perfusion defect (0=no perfusion defect; 1=mild perfusion defect; 2=moderate perfusion defect; 3=severe perfusion defect; and 4=absent perfusion). The scores over 17 segments were summed to report the Sum Rest Score (SRS), ie. the greater the SRS, the larger the perfusion defect.
TERMINATED
NA
64 participants
Baseline
2016-02-24
Participant Flow
Prospectively enroll patients with history of severe myocardial infarction, cardiomyopathy, heart failure or prior nuclear scans with resting perfusion defects. Patients were approached in the nuclear stress lab prior to scheduled stress test. Recruitment period was between 3/20/2012 and 2/14/2014.
Participant milestones
| Measure |
Study Group
Entire cohort
|
|---|---|
|
Overall Study
STARTED
|
64
|
|
Overall Study
COMPLETED
|
64
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Half-Dose Radiopharmaceutical in Wide Beam Reconstruction
Baseline characteristics by cohort
| Measure |
Study Group
n=64 Participants
Entire cohort
|
|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
|
Height
|
68.0 inches
STANDARD_DEVIATION 4.1 • n=5 Participants
|
|
Weight
|
198.4 pounds
STANDARD_DEVIATION 40.0 • n=5 Participants
|
|
Body mass index
|
30.2 kg/m^2
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Indications for stress test
Chest pain
|
16 participants
n=5 Participants
|
|
Indications for stress test
Dyspnea
|
9 participants
n=5 Participants
|
|
Indications for stress test
Prior Myocardial Infarct
|
7 participants
n=5 Participants
|
|
Indications for stress test
Prior Coronary Disease
|
18 participants
n=5 Participants
|
|
Indications for stress test
Cardiomyopathy
|
5 participants
n=5 Participants
|
|
Indications for stress test
CHF
|
6 participants
n=5 Participants
|
|
Indications for stress test
Prior CABG
|
8 participants
n=5 Participants
|
|
Indications for stress test
Prior PCI
|
5 participants
n=5 Participants
|
|
Indications for stress test
Other
|
9 participants
n=5 Participants
|
|
History
Hypertension
|
58 participants
n=5 Participants
|
|
History
Hypercholesterolemia
|
52 participants
n=5 Participants
|
|
History
Tobacco smoking (prior or current)
|
24 participants
n=5 Participants
|
|
History
Diabetes mellitus
|
21 participants
n=5 Participants
|
|
History
Family history of CAD
|
19 participants
n=5 Participants
|
|
History
Prior Myocardial Infarct
|
28 participants
n=5 Participants
|
|
History
Coronary artery disease
|
46 participants
n=5 Participants
|
|
History
Coronary artery bypass surgery
|
27 participants
n=5 Participants
|
|
Previous nuclear stress
|
39 participants
n=5 Participants
|
|
Medications
ACE inhibitors/ARB
|
33 participants
n=5 Participants
|
|
Medications
Beta-blockers
|
56 participants
n=5 Participants
|
|
Medications
Ca-channel blockers
|
19 participants
n=5 Participants
|
|
Medications
Aspirin
|
51 participants
n=5 Participants
|
|
Medications
Anti-platelet
|
21 participants
n=5 Participants
|
|
Medications
Statin
|
53 participants
n=5 Participants
|
|
Medications
Nitrates
|
11 participants
n=5 Participants
|
|
Medications
Diuretic
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineLeft ventricular myocardium was divided into standardized 17-segments with 6 equiangular segments in the basal region, 6 equiangular segments in the mid region, 4 equiangular segments in the apical regions, and 1 region in the apex (Cerqueira MD, et al., J Nucl Cardiol 2002;9:240-5). Each segment was scored on a scale from 0 to 4 to indicate the severity of the perfusion defect (0=no perfusion defect; 1=mild perfusion defect; 2=moderate perfusion defect; 3=severe perfusion defect; and 4=absent perfusion). The scores over 17 segments were summed to report the Sum Rest Score (SRS), ie. the greater the SRS, the larger the perfusion defect.
Outcome measures
| Measure |
Half-dose WBR
n=64 Participants
Half-dose Tc-99m sestamibi reconstructed using wide beam reconstruction (WBR)
|
Half-dose FBP
n=64 Participants
Half-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
|
Full-dose FBP
n=64 Participants
Full-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
|
|---|---|---|---|
|
Sum Rest Score
|
8.1 units on a scale
Standard Deviation 5.9
|
6.7 units on a scale
Standard Deviation 5.1
|
6.5 units on a scale
Standard Deviation 6.1
|
PRIMARY outcome
Timeframe: BaselineLeft ventricular myocardium was divided into standardized 17-segments with 6 equiangular segments in the basal region, 6 equiangular segments in the mid region, 4 equiangular segments in the apical regions, and 1 region in the apex (Cerqueira MD, et al., J Nucl Cardiol 2002;9:240-5). Each segment was scored on a scale from 0 to 4 to indicate the severity of the perfusion defect (0=no perfusion defect; 1=mild perfusion defect; 2=moderate perfusion defect; 3=severe perfusion defect; and 4=absent perfusion). The number of segments with a score of 1 or greater were summed to obtain the number of segments with a resting perfusion defect.
Outcome measures
| Measure |
Half-dose WBR
n=64 Participants
Half-dose Tc-99m sestamibi reconstructed using wide beam reconstruction (WBR)
|
Half-dose FBP
n=64 Participants
Half-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
|
Full-dose FBP
n=64 Participants
Full-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
|
|---|---|---|---|
|
Segments With Resting Perfusion Defect
|
4.6 segments
Standard Deviation 2.4
|
4.0 segments
Standard Deviation 2.2
|
3.8 segments
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: BaselineEach reconstructed image was subjectively scored by the expert readers to determine the overall image quality. The Image Quality Score of the reconstructed images were graded on a 4-point scale. (1=Poor; 2=Fair; 3=Good; and 4=Excellent).
Outcome measures
| Measure |
Half-dose WBR
n=64 Participants
Half-dose Tc-99m sestamibi reconstructed using wide beam reconstruction (WBR)
|
Half-dose FBP
n=64 Participants
Half-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
|
Full-dose FBP
n=64 Participants
Full-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
|
|---|---|---|---|
|
Image Quality Score
|
2.3 units on a scale
Standard Deviation 0.8
|
2.6 units on a scale
Standard Deviation 0.6
|
3.0 units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: BaselineEach reconstructed image was subjectively scored by the expert readers to determine the expert reader's diagnostic confidence in scoring and interpreting the perfusion scores. The Diagnostic Confidence Score of the reconstructed images were graded on a 4-point scale. (1=Poor; 2=Fair; 3=Good; and 4=Excellent).
Outcome measures
| Measure |
Half-dose WBR
n=64 Participants
Half-dose Tc-99m sestamibi reconstructed using wide beam reconstruction (WBR)
|
Half-dose FBP
n=64 Participants
Half-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
|
Full-dose FBP
n=64 Participants
Full-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
|
|---|---|---|---|
|
Diagnostic Confidence Score
|
2.5 units on a scale
Standard Deviation 0.8
|
2.7 units on a scale
Standard Deviation 0.9
|
3.0 units on a scale
Standard Deviation 0.8
|
POST_HOC outcome
Timeframe: BaselinePopulation: Entire Cohort
Amount of the standard, clinically-accepted, full-dose Tc-99m sestamibi dose administered
Outcome measures
| Measure |
Half-dose WBR
n=64 Participants
Half-dose Tc-99m sestamibi reconstructed using wide beam reconstruction (WBR)
|
Half-dose FBP
Half-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
|
Full-dose FBP
Full-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
|
|---|---|---|---|
|
Resting Full-Tracer Dose
|
9.08 millicurie
Standard Deviation 0.46
|
—
|
—
|
POST_HOC outcome
Timeframe: BaselineTime in minutes between doses of resting Tc-99m sestamibi doses and image scanning.
Outcome measures
| Measure |
Half-dose WBR
n=64 Participants
Half-dose Tc-99m sestamibi reconstructed using wide beam reconstruction (WBR)
|
Half-dose FBP
n=64 Participants
Half-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
|
Full-dose FBP
n=64 Participants
Full-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
|
|---|---|---|---|
|
Injection and Scan Times
|
30.0 minutes
Standard Deviation 5.4
|
33.1 minutes
Standard Deviation 13.1
|
56.7 minutes
Standard Deviation 8.2
|
Adverse Events
Study Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place