Ventricular TachycardiaEarly Phase 1NCT02962076
Study of Cardiac PET/CT Imaging to Guide Ablation Treatment of Ventricular Tachycardia
A Early Phase 1 study testing [C-11] Meta-hydroxyephedrine radioactive tracer (MHED) in people with Ventricular Tachycardia, run by Khaled Awad, MD at 1 site in United States.
Trial summary
Imaging is to be performed prior to procedure using positron emission tomography/ computed tomography (PET/CT), after a special dye is injected. The scans are going to be merged with other cardiac scans when doing the ablation procedure to correlate anatomy with physiology. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- [C-11] Meta-hydroxyephedrine radioactive tracer (MHED)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2020to 31 Oct 2024
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical indication for ventricular tachycardia (VT) ablation (at least one clinical episode of sustained VT) despite antiarrhythmic drug therapy, or if the patient does not wish to be on one
- Ischemic or nonischemic cardiomyopathy
- Sustained monomorphic VT
Who cannot join
- Right ventricular VT
- Polymorphic VT or ventricular fibrillation (VF) being the sole detected clinical arrhythmia
- Patient is unable to sign informed consent
- Recent myocardial infarction less than 30 days
- Recent ablation for ventricular tachycardia less than 30 days
- Patient is unwilling or unable to cooperate with the study
Show all 11Show fewer
- Prosthetic mitral or aortic valve
- General contraindications to VT ablation, e.g., major contraindication to anticoagulation therapy, known presence of left ventricular thrombus, reversible causes of VT or VF
- General contraindications to PET imaging, e.g., pregnancy or lactation
- General contraindication to magnetic resonance imaging or to the administration of gadolinium.
- Contraindication to the placement of hemodynamic support devices, i.e. the presence of mechanical valves or lack of adequate vascular access
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiac Positron Emission Tomography for Detection of Cardiac Sympathetic Dysinnervation to Guide Ablation of Ventricular Tachycardia
Imaging is to be performed prior to procedure using positron emission tomography/ computed tomography (PET/CT), after a special dye is injected. The scans are going to be merged with other cardiac scans when doing the ablation procedure to correlate anatomy with physiology.
- Conditions
- Ventricular Tachycardia
- Being tested
- [C-11] Meta-hydroxyephedrine radioactive tracer (MHED)
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[C-11] Meta-hydroxyephedrine radioactive tracer (MHED)Drug
this tracer detects the distribution of sympathetic nerve fibers in the left ventricle
| Study group | Role | What they receive |
|---|---|---|
| Single Arm - PET/CT Imaging With [C-11] MHED | Experimental | Single Arm - positron emission tomography/computed tomography imaging with [C-11] meta-Hydroxyephedrine tracer Receives: Drug: [C-11] Meta-hydroxyephedrine radioactive tracer (MHED) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between PET Data and Electroanatomic Data
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study start21 Sep 2020
- Primary completion1 Mar 2023
- Study completion31 Oct 2024
Why it stopped: Investigator departing institution and enrollment not met.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khaled Awad, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Khaled Awad, MD, Mercy Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962076
- Sponsor's protocol ID
- F141013002
- Status last verified
- Nov 2024
- First submitted
- 9 Nov 2016
- Last updated
- 24 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Positron Emission Tomography for Detection of Cardiac Sympathetic Dysinnervation to Guide Ablation of Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT02962076
- Acronym / sponsor ID
- F141013002
- Conditions
- Ventricular Tachycardia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator departing institution and enrollment not met.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Khaled Awad, MDUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc., Washington University School of Medicine
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Posted 24 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Imaging is to be performed prior to procedure using positron emission tomography/ computed tomography (PET/CT), after a special dye is injected. The scans are going to be merged with other cardiac scans when doing the ablation procedure to correlate anatomy with physiology.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm - PET/CT Imaging With [C-11] MHED | Experimental | Drug: [C-11] Meta-hydroxyephedrine radioactive tracer (MHED)Single Arm - positron emission tomography/computed tomography imaging with [C-11] meta-Hydroxyephedrine tracer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical indication for ventricular tachycardia (VT) ablation (at least one clinical episode of sustained VT) despite antiarrhythmic drug therapy, or if the patient does not wish to be on one
- Ischemic or nonischemic cardiomyopathy
- Sustained monomorphic VT
Key exclusion criteria (11 listed)
- Right ventricular VT
- Polymorphic VT or ventricular fibrillation (VF) being the sole detected clinical arrhythmia
- Patient is unable to sign informed consent
- Recent myocardial infarction less than 30 days
- Recent ablation for ventricular tachycardia less than 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [C-11] Meta-hydroxyephedrine radioactive tracer (MHED)this tracer detects the distribution of sympathetic nerve fibers in the left ventricle | Drug | Single Arm - PET/CT Imaging With [C-11] MHED |
Primary outcome
Correlation Between PET Data and Electroanatomic Data
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [C-11] Meta-hydroxyephedrine radioactive tracer (MHED) in people with Ventricular Tachycardia, run by Khaled Awad, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between PET Data and Electroanatomic Data (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.