Trial Outcomes & Findings for Clinical Comparison of Electrocardiograms Collected Using an Ambulatory Holter (NCT NCT02383667)

NCT ID: NCT02383667

Last Updated: 2019-10-07

Results Overview

quality of data obtained between harness and holter. Subjective evaluation: -Quality of the data will be rated on a 0 - 10 scale with 0 being unreadable and 10 being excellent

• Recruitment status: COMPLETED
• Target enrollment: 20 participants
• Primary outcome timeframe: 15 minutes
• Results posted on: 2019-10-07

Participant Flow

recruitment was done in the hospital setting with patients that were admitted. start of enrollment was 3/26/2013-3/9/15.

Participant milestones

Measure	Patients With Electrocardiograms Any patient within the hospital either for procedure or for admission will be screened. Patients will be simultaneously be hooked up to two ambulatory Holter monitors for the period of time to be not less than one hour. One holter will use standard electrodes in a standard electrode distribution. The second holter will use dry electrodes in a derived; data will be collected for 1-6 hours. After the data is collected the Holters will be removed and the data will be downloaded into the reading software to be scanned. Electrocardiogram holter
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Comparison of Electrocardiograms Collected Using an Ambulatory Holter

Baseline characteristics by cohort

Measure	Patients With Electrocardiograms n=20 Participants Any patient within the hospital either for procedure or for admission will be screened. Patients will be simultaneously be hooked up to two ambulatory Holter monitors for the period of time to be not less than one hour. One holter will use standard electrodes in a standard electrode distribution. The second holter will use dry electrodes in a derived; data will be collected for 1-6 hours. After the data is collected the Holters will be removed and the data will be downloaded into the reading software to be scanned. Electrocardiogram holter
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants
Age, Continuous	74.6 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 15 minutes

Population: there were 13 females and 7 males, mean age of 74.65

quality of data obtained between harness and holter.

Subjective evaluation:

-Quality of the data will be rated on a 0 - 10 scale with 0 being unreadable and 10 being excellent

Outcome measures

Measure	Patients With Electrocardiograms n=20 Participants Any patient within the hospital either for procedure or for admission will be screened. Patients will be simultaneously be hooked up to two ambulatory Holter monitors for the period of time to be not less than one hour. One holter will use standard electrodes in a standard electrode distribution. The second holter will use dry electrodes in a derived; data will be collected for 1-6 hours. After the data is collected the Holters will be removed and the data will be downloaded into the reading software to be scanned. Electrocardiogram holter
Arrythmia harness	4.6 Quality rating Standard Deviation 2.30332
Arrythmia holter	7.95 Quality rating Standard Deviation 1.877715

Adverse Events

Patients With Electrocardiograms

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Saima Karim, DO

The University of Toledo

Phone: 419-383-3697

Email: Saima.Karim@utoledo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place