- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03218137
Use of Adenosine to Determine the Electrophysiological Mechanism of Premature Ventricular Contractions
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The cellular mechanism of premature ventricular contractions (PVCs) is unknown. The investigators have previously observed that 5% of patients in the investigators electrophysiology laboratory with ventricular outflow tract PVCs have inducible sustained ventricular tachycardia (VT) that behaves in a manner similar to patients who present clinically with sustained ventricular tachycardia, i.e., sensitive to adenosine and triggered activity. This suggests that outflow arrhythmias may be a continuum of a single mechanism.
Adenosine is known to terminate ventricular arrhythmias that are due to triggered activity (ref Lerman). To study the effects of adenosine on PVC, the investigators will administer Verapamil to slow down the heart initially and adenosine after catheters are introduced to patients who are being treated for symptomatic PVC and have consented to treatment with an invasive electrophysiology study and catheter ablation. The investigators will observe if there is any effect of reduced PVC following adenosine administration.
The investigators hypothesize that PVC will be suppressed by exogenous adenosine and/or verapamil. The information from this study will elucidate the underlying cellular mechanism of this common arrhythmia. Such knowledge could potentially lead to developing therapeutic targets. Moreover, it will have potential clinical applications for inducing outflow tract PVCs/VT in patients whose arrhythmia is suppressed at the time of their invasive electrophysiology study.
Analysis of the Holter recording of premature ventricular contractions:
Analysis of the PVC coupling intervals can be helpful for delineating the mechanism of PVCs. Holter monitors are being obtained on these patients prior to ablation as part of standard of care. Holters monitors, if performed at our institution, will be analyzed in detail in a retrospective fashion. Holter reports from 1/1/2015 - 5/15/2019 will be reviewed.
Specifically, evaluating the time intervals between PVCs and normal heart beats may elucidate potential arrhythmia mechanism as triggered activity or modulated parasystole. Since a subject has approximately 100,000 heart beats in 24 hours, the Holter data have to be read by a converter file and outputted to an Excel file for our further analysis. The investigators do not have access to a converter file and it is not commercially available. The investigators will send the de-identified data to Dr. Mortara at UCSF. The investigators will then analyze the timing intervals among PVCs and normal heart beats. It should be noted that these Holters are obtained as part of a patient's normal evaluation and are not obtained for the purposes of this study.
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: James E Ip, M.D
- Phone Number: 212 746 2158
- Email: jei9008@med.cornell.edu
Study Contact Backup
- Name: Dolores T Reynolds, BSN
- Phone Number: 212 746 4617
- Email: dtr2001@med.cornell.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Recruiting
- Weill Cornell Medicine
-
Contact:
- James E Ip, M.D
- Phone Number: 212 746 2158
- Email: jei9008@med.cornell.edu
-
Contact:
- Dolores T Reynolds, BSN
- Phone Number: 212-746-4617
- Email: dtr2001@med.cornell.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of premature ventricular contractions (PVCs)
- Scheduled to undergo an electrophysiology study with the intention of performing cardiac ablation for the treatment of PVCs
- Male or female between the ages of 18 and 70 years
- Capable of giving informed consent
Exclusion Criteria:
- Any structural heart disease
- Coronary artery disease (≥ 70% stenosis)
- Current treatment with anti-arrhythmic drugs
- Pregnant
- Asthma (if administering adenosine)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Adenosine/ Verapamil Arm
Adenosine: 0.84 mg/kg IV (140 mcg/kg/minute IV for 6 minutes) Verapamil: 0.15 mg/kg IV Adenosine is known to terminate ventricular arrhythmias that are due to triggered activity (ref Lerman). To study the effects of adenosine on PVC, the investigators will administer Verapamil to slow down the heart initially and adenosine after catheters are introduced to patients who are being treated for symptomatic PVC and have consented to treatment with an invasive electrophysiology study and catheter ablation. |
Adenosine: 0.84 mg/kg (140 mcg/kg/minute IV for 6 minutes) Verapamil 0.15 mg/kg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of Adenosine on premature ventricular contractions (PVCs) as measured by EKG;
Time Frame: baseline
|
The metrics that will be collected will be:
|
baseline
|
Effects of verapamil on premature ventricular contractions (PVCs) as measured by EKGs.
Time Frame: baseline
|
The metrics that will be collected will be:
|
baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: James E Ip, M.D, Weill Medical College of Cornell University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Arrhythmias, Cardiac
- Cardiac Conduction System Disease
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Cardiac Complexes, Premature
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Premature Birth
- Ventricular Premature Complexes
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Vasodilator Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Purinergic Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Purinergic P1 Receptor Agonists
- Purinergic Agonists
- Adenosine
- Verapamil
Other Study ID Numbers
- 1609017561
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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