Arrhythmia, Ventricular Tachycardia
Conditions
Keywords
Ablation, Arrythmia, Imaging
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.
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.
Interventions
DRUG123I-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.
Sponsors
GE Healthcare
University of Maryland, Baltimore
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MIBG Imaging on Top of Standard of Care VT Ablation 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. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | MIBG Imaging on Top of Standard of Care VT Ablation |
|---|---|
| Age, Continuous | 68.5 years STANDARD_DEVIATION 8.6 |
| Comorbidities Atrial Fibrillation | 7 Participants |
| Comorbidities Diabetes Mellitus | 6 Participants |
| Comorbidities Hyperlipidemia | 12 Participants |
| Comorbidities Hypertension | 16 Participants |
| Ejection Fraction | 12.3 percent of LV ejection fraction STANDARD_DEVIATION 25.2 |
| NYHA Heart Class NYHA I (Asymptomatic) Best category | 0 Participants |
| NYHA Heart Class NYHA II (Dyspnea on severe activity) | 7 Participants |
| NYHA Heart Class NYHA III (Dyspnea on ordinary activity | 11 Participants |
| NYHA Heart Class NYHA IV (Dyspnea at rest) Worst category | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 1 / 20 |
Outcome results
Primary
Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at 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.
Time frame: Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MIBG/SPECT | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Basal Anterior | 2 Participants |
| MIBG/SPECT | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | basal Anteroseptal | 1 Participants |
| MIBG/SPECT | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Basal Inferoseptal | 11 Participants |
| MIBG/SPECT | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Basal Inferior | 18 Participants |
| MIBG/SPECT | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Basal Anterolateral | 16 Participants |
| MIBG/SPECT | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Mid Anterior | 2 Participants |
| MIBG/SPECT | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Mid Anteroseptal | 3 Participants |
| MIBG/SPECT | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Mid Inferoseptal | 14 Participants |
| MIBG/SPECT | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Mid Inferior | 15 Participants |
| MIBG/SPECT | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Mid Inferolateral | 13 Participants |
| MIBG/SPECT | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Mid Anterolateral | 3 Participants |
| MIBG/SPECT | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Apical Anterior | 2 Participants |
| MIBG/SPECT | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Apical Septal | 12 Participants |
| MIBG/SPECT | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Apical Inferior | 14 Participants |
| MIBG/SPECT | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Apical Lateral | 11 Participants |
| MIBG/SPECT | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Apex | 11 Participants |
| Electroanatomic Imaging Assessment | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Apex | 8 Participants |
| Electroanatomic Imaging Assessment | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Basal Anterior | 4 Participants |
| Electroanatomic Imaging Assessment | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Mid Inferior | 13 Participants |
| Electroanatomic Imaging Assessment | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | basal Anteroseptal | 4 Participants |
| Electroanatomic Imaging Assessment | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Apical Septal | 9 Participants |
| Electroanatomic Imaging Assessment | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Basal Inferoseptal | 9 Participants |
| Electroanatomic Imaging Assessment | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Mid Inferolateral | 10 Participants |
| Electroanatomic Imaging Assessment | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Basal Inferior | 10 Participants |
| Electroanatomic Imaging Assessment | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Apical Lateral | 8 Participants |
| Electroanatomic Imaging Assessment | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Basal Anterolateral | 13 Participants |
| Electroanatomic Imaging Assessment | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Mid Anterolateral | 4 Participants |
| Electroanatomic Imaging Assessment | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Mid Anterior | 6 Participants |
| Electroanatomic Imaging Assessment | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Apical Inferior | 11 Participants |
| Electroanatomic Imaging Assessment | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Mid Anteroseptal | 6 Participants |
| Electroanatomic Imaging Assessment | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Apical Anterior | 4 Participants |
| Electroanatomic Imaging Assessment | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Mid Inferoseptal | 11 Participants |
Secondary
Median Segmental MIBG Uptake at 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.
Time frame: 6 months after ablation
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MIBG/SPECT | Median Segmental MIBG Uptake at 6 Months After Ablation | 48 percentage of maximum uptake |
Secondary
Median Segmental MIBG Uptake at Baseline
The median uptake of the standard 17 heart segments was determined at baseline
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MIBG/SPECT | Median Segmental MIBG Uptake at Baseline | 52 percentage of maximum uptake |