Imaging With a Radio Tracer to Guide VT Ablations
Study Details
Study Description
Brief Summary
Some patients are at risk for life-threatening fast heart rates. These can frequently be treated by using a catheter inside the heart to burn away the cells that create the fast heart rates. The purpose of this study is to image the nerves inside the heart of those patients. The investigators want to find out if abnormalities in the nervous system in the heart can help the physician to find the area that needs to be burnt away.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Detailed Description
Ventricular tachycardia is the next frontier in cardiology. Patients that have scar in the heart (for example after heart attacks) are at an increased risk of developing ventricular tachycardia. In these patients ventricular tachycardia represents an electrical wave front that circulates in the heart muscle using the scar in the heart. An increasing number of patients with ventricular tachycardia require cauterization (burning away) of the tissue to treat this life-threatening condition. The goal of this cauterization or ablation is to destroy "highways of surviving tissue" inside the scar, that allow ventricular tachycardia to exist. However, this can be very lengthy procedure (>5 hours) that has only a moderate success in the long run. Therefore, new treatment approaches are needed to make this procedure better.
The purpose of this study is to assess if radio tracers showing the nerve distribution in the heart (cardiac innervation) can be used in addition to the current technology ("voltage mapping") to identify the area that needs to be ablated (burnt away) to treat life-threatening fast heart rates (ventricular tachycardia)
Certain patterns of nerve distribution in the heart (sympathetic cardiac innervation) have been shown to predict outcome for different heart diseases, like heart transplant, coronary artery disease, heart failure, arrhythmias. One substance that allows visualization of the cardiac innervation is 123I-metaiodobenzylguanidine (123I-MIBG), which could provide additional information to understand and treat ventricular tachycardia.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Imaging Tracer No arms, the Radio tracer will be used in all subjects imaging tests. |
Drug: 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline [Baseline]
Scar Measurement on both MIBG 3D map and electroanatomic scare defined as bipolar voltage <0.5mV using Standard 17-segment American Heart Association areas.
Secondary Outcome Measures
- Median Segmental MIBG Uptake at Baseline [Baseline]
The median uptake of the standard 17 heart segments was determined at baseline
- Median Segmental MIBG Uptake at 6 Months After Ablation [6 months after ablation]
MIBG/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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with ventricular arrhythmias requiring VT Ablation
-
Patients must be 18 years of age or older
-
Patient must be able to sign consent form
-
Patient must be willing to come back for the 6 month visit for additional study procedures
Exclusion Criteria:
-
Patient under 18 years old
-
Inability to sign consent
-
Pregnant Women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Maryland Medical Center, EP Lab, Rm. N3W77 | Baltimore | Maryland | United States | 21201 |
Sponsors and Collaborators
- University of Maryland, Baltimore
- GE Healthcare
Investigators
- Principal Investigator: Timm R Dickfeld, MD,Ph.D, University of Maryland Medical Center
Study Documents (Full-Text)
More Information
Publications
- Dickfeld T, Kocher C. The role of integrated PET-CT scar maps for guiding ventricular tachycardia ablations. Curr Cardiol Rep. 2008 Mar;10(2):149-57. Review.
- Tian J, Smith MF, Chinnadurai P, Dilsizian V, Turgeman A, Abbo A, Gajera K, Xu C, Plotnick D, Peters R, Saba M, Shorofsky S, Dickfeld T. Clinical application of PET/CT fusion imaging for three-dimensional myocardial scar and left ventricular anatomy during ventricular tachycardia ablation. J Cardiovasc Electrophysiol. 2009 Jun;20(6):567-604.
- Tian J, Smith MF, Jeudy J, Dickfeld T. Multimodality fusion imaging using delayed-enhanced cardiac magnetic resonance imaging, computed tomography, positron emission tomography, and real-time intracardiac echocardiography to guide ventricular tachycardia ablation in implantable cardioverter-defibrillator patients. Heart Rhythm. 2009 Jun;6(6):825-8. doi: 10.1016/j.hrthm.2009.02.032. Epub 2009 Feb 24.
- HP-00043324
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Patients Receiving MIBG Imaging |
|---|---|
| Arm/Group Description | All patients received MIBG imaging before and 6 months after VT ablation |
| Period Title: Overall Study | |
| STARTED | 20 |
| COMPLETED | 19 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | MIBG Imaging on Top of Standard of Care VT Ablation |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 20 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
68.5
(8.6)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
8
40%
|
| Male |
12
60%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
3
15%
|
| White |
17
85%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Ejection Fraction (percent of LV ejection fraction) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [percent of LV ejection fraction] |
12.3
(25.2)
|
| Comorbidities (Count of Participants) | |
| Diabetes Mellitus |
6
30%
|
| Hypertension |
16
80%
|
| Hyperlipidemia |
12
60%
|
| Atrial Fibrillation |
7
35%
|
| NYHA Heart Class (Count of Participants) | |
| NYHA I (Asymptomatic) Best category |
0
0%
|
| NYHA II (Dyspnea on severe activity) |
7
35%
|
| NYHA III (Dyspnea on ordinary activity |
11
55%
|
| NYHA IV (Dyspnea at rest) Worst category |
2
10%
|
Outcome Measures
| Title | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline |
|---|---|
| Description | Scar Measurement on both MIBG 3D map and electroanatomic scare defined as bipolar voltage <0.5mV using Standard 17-segment American Heart Association areas. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | MIBG/SPECT | Electroanatomic Imaging Assessment |
|---|---|---|
| Arm/Group Description | Assessment by MIBG/SPECT | Assessment electroanatomic by a bipolar voltage of <0.5 mV. |
| Measure Participants | 20 | 20 |
| Basal Anterior |
2
10%
|
4
NaN
|
| basal Anteroseptal |
1
5%
|
4
NaN
|
| Basal Inferoseptal |
11
55%
|
9
NaN
|
| Basal Inferior |
18
90%
|
10
NaN
|
| Basal Anterolateral |
16
80%
|
13
NaN
|
| Mid Anterior |
2
10%
|
6
NaN
|
| Mid Anteroseptal |
3
15%
|
6
NaN
|
| Mid Inferoseptal |
14
70%
|
11
NaN
|
| Mid Inferior |
15
75%
|
13
NaN
|
| Mid Inferolateral |
13
65%
|
10
NaN
|
| Mid Anterolateral |
3
15%
|
4
NaN
|
| Apical Anterior |
2
10%
|
4
NaN
|
| Apical Septal |
12
60%
|
9
NaN
|
| Apical Inferior |
14
70%
|
11
NaN
|
| Apical Lateral |
11
55%
|
8
NaN
|
| Apex |
11
55%
|
8
NaN
|
| Title | Median Segmental MIBG Uptake at Baseline |
|---|---|
| Description | The median uptake of the standard 17 heart segments was determined at baseline |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | MIBG Imaging at Baseline |
|---|---|
| Arm/Group Description | MIBG/SPECT imaging prior to the 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. |
| Measure Participants | 19 |
| Median (Inter-Quartile Range) [percentage of maximum uptake] |
52
|
| Title | Median Segmental MIBG Uptake at 6 Months After Ablation |
|---|---|
| Description | MIBG/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. |
| Time Frame | 6 months after ablation |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | MIBG Imaging at 6 Months |
|---|---|
| Arm/Group Description | MIBG/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. |
| Measure Participants | 19 |
| Mean (Inter-Quartile Range) [percentage of maximum uptake] |
48
|
Adverse Events
| Time Frame | 6 months | |
|---|---|---|
| Adverse Event Reporting Description | Clinicaltrials.gov definitions were used | |
| Arm/Group Title | MIBG Imaging on Top of Standard of Care VT Ablation | |
| Arm/Group Description | 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. | |
All Cause Mortality |
||
| MIBG Imaging on Top of Standard of Care VT Ablation | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/20 (5%) | |
Serious Adverse Events |
||
| MIBG Imaging on Top of Standard of Care VT Ablation | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/20 (5%) | |
| General disorders | ||
| Death due to unrelated non cardiac cause | 1/20 (5%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| MIBG Imaging on Top of Standard of Care VT Ablation | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Timm-Michael Dickfeld |
|---|---|
| Organization | University of Maryland, Baltimore |
| Phone | 410-328-7801 |
| tdickfel@som.umaryland.edu |
- HP-00043324