Trial Outcomes & Findings for Imaging With a Radio Tracer to Guide VT Ablations (NCT NCT01250912)
NCT ID: NCT01250912
Last Updated: 2022-01-27
Results Overview
Scar Measurement on both MIBG 3D map and electroanatomic scare defined as bipolar voltage \<0.5mV using Standard 17-segment American Heart Association areas.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Baseline
Results posted on
2022-01-27
Participant Flow
Participant milestones
| Measure |
Patients Receiving MIBG Imaging
All patients received MIBG imaging before and 6 months after VT ablation
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Patients Receiving MIBG Imaging
All patients received MIBG imaging before and 6 months after VT ablation
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Imaging With a Radio Tracer to Guide VT Ablations
Baseline characteristics by cohort
| Measure |
MIBG Imaging on Top of Standard of Care VT Ablation
n=20 Participants
MIBG/SPECT imaging prior to, and 6 months after the ablation. 123I-metaiodobenzylguanidine: FDA Approved for use in Cancer patients. This use is Off Label. For the imaging study, an activity of 370 MBq (10 mCi) 123I-mIBG (GE Healthcare) will be administered intravenously, and a 10-minute planar image of the anterior thorax (128\_128 matrix) will be acquired beginning 15 minutes after tracer injection.
|
|---|---|
|
Age, Continuous
|
68.5 years
STANDARD_DEVIATION 8.6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Ejection Fraction
|
12.3 percent of LV ejection fraction
STANDARD_DEVIATION 25.2 • n=99 Participants
|
|
Comorbidities
Diabetes Mellitus
|
6 Participants
n=99 Participants
|
|
Comorbidities
Hypertension
|
16 Participants
n=99 Participants
|
|
Comorbidities
Hyperlipidemia
|
12 Participants
n=99 Participants
|
|
Comorbidities
Atrial Fibrillation
|
7 Participants
n=99 Participants
|
|
NYHA Heart Class
NYHA I (Asymptomatic) Best category
|
0 Participants
n=99 Participants
|
|
NYHA Heart Class
NYHA II (Dyspnea on severe activity)
|
7 Participants
n=99 Participants
|
|
NYHA Heart Class
NYHA III (Dyspnea on ordinary activity
|
11 Participants
n=99 Participants
|
|
NYHA Heart Class
NYHA IV (Dyspnea at rest) Worst category
|
2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: BaselineScar Measurement on both MIBG 3D map and electroanatomic scare defined as bipolar voltage \<0.5mV using Standard 17-segment American Heart Association areas.
Outcome measures
| Measure |
MIBG/SPECT
n=20 Participants
Assessment by MIBG/SPECT
|
Electroanatomic Imaging Assessment
n=20 Participants
Assessment electroanatomic by a bipolar voltage of \<0.5 mV.
|
|---|---|---|
|
Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline
Basal Anterior
|
2 Participants
|
4 Participants
|
|
Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline
basal Anteroseptal
|
1 Participants
|
4 Participants
|
|
Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline
Basal Inferoseptal
|
11 Participants
|
9 Participants
|
|
Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline
Basal Inferior
|
18 Participants
|
10 Participants
|
|
Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline
Basal Anterolateral
|
16 Participants
|
13 Participants
|
|
Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline
Mid Anterior
|
2 Participants
|
6 Participants
|
|
Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline
Mid Anteroseptal
|
3 Participants
|
6 Participants
|
|
Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline
Mid Inferoseptal
|
14 Participants
|
11 Participants
|
|
Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline
Mid Inferior
|
15 Participants
|
13 Participants
|
|
Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline
Mid Inferolateral
|
13 Participants
|
10 Participants
|
|
Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline
Mid Anterolateral
|
3 Participants
|
4 Participants
|
|
Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline
Apical Anterior
|
2 Participants
|
4 Participants
|
|
Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline
Apical Septal
|
12 Participants
|
9 Participants
|
|
Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline
Apical Inferior
|
14 Participants
|
11 Participants
|
|
Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline
Apical Lateral
|
11 Participants
|
8 Participants
|
|
Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline
Apex
|
11 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: BaselineThe median uptake of the standard 17 heart segments was determined at baseline
Outcome measures
| Measure |
MIBG/SPECT
n=19 Participants
Assessment by MIBG/SPECT
|
Electroanatomic Imaging Assessment
Assessment electroanatomic by a bipolar voltage of \<0.5 mV.
|
|---|---|---|
|
Median Segmental MIBG Uptake at Baseline
|
52 percentage of maximum uptake
Interval 50.0 to 62.0
|
—
|
SECONDARY outcome
Timeframe: 6 months after ablationMIBG/SPECT imaging 6 months after ablation. 123I-metaiodobenzylguanidine: For the imaging study, an activity of 370 MBq (10 mCi) 123I-mIBG (GE Healthcare) was administered intravenously, and a 10-minute planar image of the anterior thorax (128\_128 matrix) was acquired beginning 15 minutes after tracer injection.
Outcome measures
| Measure |
MIBG/SPECT
n=19 Participants
Assessment by MIBG/SPECT
|
Electroanatomic Imaging Assessment
Assessment electroanatomic by a bipolar voltage of \<0.5 mV.
|
|---|---|---|
|
Median Segmental MIBG Uptake at 6 Months After Ablation
|
48 percentage of maximum uptake
Interval 46.0 to 56.0
|
—
|
Adverse Events
MIBG Imaging on Top of Standard of Care VT Ablation
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
MIBG Imaging on Top of Standard of Care VT Ablation
n=20 participants at risk
MIBG/SPECT imaging prior to, and 6 months after the ablation. For the imaging study, an activity of 370 MBq (10 mCi) 123I-mIBG (GE Healthcare) will be administered intravenously, and a 10-minute planar image of the anterior thorax (128\_128 matrix) will be acquired beginning 15 minutes after tracer injection.
|
|---|---|
|
General disorders
Death due to unrelated non cardiac cause
|
5.0%
1/20 • Number of events 1 • 6 months
Clinicaltrials.gov definitions were used
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Timm-Michael Dickfeld
University of Maryland, Baltimore
Phone: 410-328-7801
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place