Trial Outcomes & Findings for ST-segment Elevation as an AF Endophenotype (NCT NCT01205529)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

161 participants

Primary outcome timeframe

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

Results posted on

2018-05-02

Participant Flow

Participant milestones

Participant milestones
Measure	Atrial Fibrillation With ST Changes on Electrocardiogram 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 also have SCN5A mutation. Procainamide: One time intravenous infusion of Procainamide administered over 30 minutes. Dosage is calculated as 10mg/kg based on subject's ideal body weight.
Overall Study STARTED	161
Overall Study COMPLETED	106
Overall Study NOT COMPLETED	55

Reasons for withdrawal

Reasons for withdrawal
Measure	Atrial Fibrillation With ST Changes on Electrocardiogram 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 also have SCN5A mutation. Procainamide: One time intravenous infusion of Procainamide administered over 30 minutes. Dosage is calculated as 10mg/kg based on subject's ideal body weight.
Overall Study Procedure Cancelled	4
Overall Study Withdrawal by Subject	2
Overall Study Physician Decision	4
Overall Study Unstable post op	15
Overall Study No longer met criteria	30

Baseline Characteristics

ST-segment Elevation as an AF Endophenotype

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atrial Fibrillation With ST Changes on Electrocardiogram n=161 Participants 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 also have SCN5A mutation. Procainamide: One time intravenous infusion of Procainamide administered over 30 minutes. Dosage is calculated as 10mg/kg based on subject's ideal body weight.
Age, Continuous	55 years n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	120 Participants n=5 Participants
Region of Enrollment United States	161 participants n=5 Participants

PRIMARY outcome

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

Population: Number of subject who had \>/= 1.5mm right precordial ST-segment elevation at baseline or with procainamide administration

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.

Outcome measures

Outcome measures
Measure	Atrial Fibrillation With ST Changes on Electrocardiogram n=89 Participants 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. Procainamide: One time intravenous infusion of Procainamide administered over 30 minutes. Dosage is calculated as 10mg/kg based on subject's ideal body weight.
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	4 Participants

Adverse Events

Atrial Fibrillation With ST Changes on Electrocardiogram

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Atrial Fibrillation With ST Changes on Electrocardiogram n=106 participants at risk 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 also have SCN5A mutation. Procainamide: One time intravenous infusion of Procainamide administered over 30 minutes. Dosage is calculated as 10mg/kg based on subject's ideal body weight.
Nervous system disorders Cerebrovascular accident (CVA) post ablation	0.94% 1/106 • Number of events 1 • 1 hour Adverse events definitions match ClinicalTrials.gov

Other adverse events

Other adverse events
Measure	Atrial Fibrillation With ST Changes on Electrocardiogram n=106 participants at risk 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 also have SCN5A mutation. Procainamide: One time intravenous infusion of Procainamide administered over 30 minutes. Dosage is calculated as 10mg/kg based on subject's ideal body weight.
Blood and lymphatic system disorders Hypotension	0.94% 1/106 • Number of events 1 • 1 hour Adverse events definitions match ClinicalTrials.gov
Gastrointestinal disorders Nause/Vomiting	3.8% 4/106 • Number of events 4 • 1 hour Adverse events definitions match ClinicalTrials.gov
Cardiac disorders Prolonged QT	0.94% 1/106 • Number of events 1 • 1 hour Adverse events definitions match ClinicalTrials.gov

Additional Information

Dan Roden

Vanderbilt University Medical Center

Phone: 6153220067

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place