NCT01205529

Brief Summary

The purpose of this study is to look for a similarity in people's genes that may help understand which people could benefit from certain drugs for the treatment of atrial fibrillation (AF).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Nov 2010

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

May 2, 2018

Completed
Last Updated

May 2, 2018

Status Verified

March 1, 2018

Enrollment Period

4.6 years

First QC Date

September 17, 2010

Results QC Date

September 20, 2017

Last Update Submit

March 29, 2018

Conditions

Atrial Fibrillation

Keywords

Atrial FibrillationST elevationGenotype

Outcome Measures

Primary Outcomes (1)

  • ST Segment Elevation ≥ 1.5 mm in the Right Precordial Leads (V1-V3), Either at Baseline or Manifested After Sodium Channel Block With Intravenous Procainamide

    Number of participants who demonstrated ST-segment elevation \>1.5mm in the right precordial leads (V1-V3) either at baseline or after sodium channel block with intravenous procainamide infusion.

    During (5, 10, 15, 20, 25, 30 minutes after initiating) or up to 15 minutes after completion of intravenous procainamide infusion

Study Arms (1)

AF with ST changes on ECG

OTHER

Those patients with ST segment or J Point elevation on electrocardiogram. Can be on initial screening electrocardiogram or on electrocardiograms during procainamide infusion. These subjects will harbor cardiac sodium channel gene variants.

Drug: Procainamide

Interventions

ProcainamideDRUG

One time intravenous infusion of Procainamide administered over 30 minutes. Dosage is calculated as 10mg/kg based on subject's ideal body weight.

AF with ST changes on ECG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Undergoing AF ablation at Vanderbilt or MGH

You may not qualify if:

  • Patients taking membrane active anti-arrhythmic drugs with sodium channel blocking properties (amiodarone, dronedarone, flecainide, propafenone) at the time of the ablation
  • Patients with a history of Brugada syndrome or type 1 Brugada ECG pattern on the baseline ECG
  • Patients with a history of drug-induced torsades de pointes
  • Patients with a known history of hypersensitivity to procainamide, procaine or related drugs
  • Patients with a history of systemic lupus erythematosus and myasthenia gravis
  • Patients with a history of second degree AV block (Mobitz type II) or third degree AV block
  • Women of child-bearing potential unless post-menopausal, surgically sterile, or have a negative pregnancy test day on the day of procedure
  • Patients with dual chamber pacemakers or implantable defibrillators requiring ventricular pacing (uninterpretable ECG)
  • Patients unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Procainamide

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic Chemicalspara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Results Point of Contact

Title
Dan Roden
Organization
Vanderbilt University Medical Center
dan.roden@Vanderbilt.Edu
6153220067

Study Officials

  • Dawood Darbar, MD, PhD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
All participants and investigators were blinded to the genetic sequencing results at the time of outcome ascertainment
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 17, 2010

First Posted

September 20, 2010

Study Start

November 1, 2010

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

May 2, 2018

Results First Posted

May 2, 2018

Record last verified: 2018-03

Locations

US(1)