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Trial record 1 of 1242 for:    adenosine
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Use of Adenosine to Determine the Electrophysiological Mechanism of Premature Ventricular Contractions

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ClinicalTrials.gov Identifier: NCT03218137
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE June 29, 2017
First Posted Date  ICMJE July 14, 2017
Last Update Posted Date May 30, 2019
Actual Study Start Date  ICMJE February 13, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
  • Effects of Adenosine on premature ventricular contractions (PVCs) as measured by EKG; [ Time Frame: baseline ]
    The metrics that will be collected will be:
    • Baseline frequency of premature ventricular contractions (PVCs)
    • Frequency of premature ventricular contractions (PVCs) during adenosine administration
  • Effects of verapamil on premature ventricular contractions (PVCs) as measured by EKGs. [ Time Frame: baseline ]
    The metrics that will be collected will be:
    • Baseline frequency of premature ventricular contractions (PVCs)
    • Frequency of premature ventricular contractions (PVCs) during verapamil administration
Original Primary Outcome Measures  ICMJE
 (submitted: July 13, 2017)
To determine if premature ventricular contractions (PVCs) are suppressed by adenosine [ Time Frame: 1 day ]
The metrics that will be collected will be:
  • Baseline frequency of premature ventricular contractions (PVCs)
  • Frequency of premature ventricular contractions (PVCs) during adenosine administration
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Adenosine to Determine the Electrophysiological Mechanism of Premature Ventricular Contractions
Official Title  ICMJE Use of Adenosine to Determine the Electrophysiological Mechanism of Premature Ventricular Contractions
Brief Summary Unblinded, controlled, non-randomized, mechanistic study to determine whether physiological mechanisms underlying PVC are sensitive to adenosine. One hundred subjects undergoing clinically-indicated, standard-of-care cardiac electrophysiology study (EPS) procedure for PVCs will receive adenosine and/or verapamil to learn if their arrhythmias are inducible similarly to sustained ventricular tachycardia.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Premature Ventricular Contraction (PVC)
Intervention  ICMJE Drug: Adenosine
Adenosine: 0.84 mg/kg (140 mcg/kg/minute IV for 6 minutes) Verapamil 0.15 mg/kg
Other Name: Verapamil 0.15 mg/kg
Study Arms  ICMJE 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.

Intervention: Drug: Adenosine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 23, 2019)
100
Original Estimated Enrollment  ICMJE
 (submitted: July 13, 2017)
20
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: James E Ip, M.D 212 746 2158 jei9008@med.cornell.edu
Contact: Dolores T Reynolds, BSN 212 746 4617 dtr2001@med.cornell.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03218137
Other Study ID Numbers  ICMJE 1609017561
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James E Ip, M.D Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP