Clinical Comparison of Electrocardiograms Collected Using an Ambulatory Holter

NCT02383667 | Completed Results

• 1 other identifier: Orbital
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to compare electrocardiograms using ambulatory holter monitor with dry electrodes in a harness versus using an ambulatory holter with standard sticky electrodes (Red Dot) on monitored patients within the hospital. 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.

Conditions

Electrocardiography

Outcome Measures

Primary Outcomes (1)

• Arrythmia

  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

  15 minutes

Study Arms (1)

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.

Device: Electrocardiogram holter

Interventions

Electrocardiogram holter DEVICE

Patients with Electrocardiograms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients within the hospital either for a procedure or for admission

You may qualify if:

• Any patient within the hospital either for procedure or for admission

You may not qualify if:

• Patients who cannot wear a Holter monitor
• Patients undergoing an MRI or have other contraindications for wearing an ambulatory Holter monitor.

Sponsors & Collaborators

• University of Toledo Health Science Campus: lead

Study Sites (1)

University of Toledo, Health Science Campus

Toledo, Ohio, 43606, United States

Location

Results Point of Contact

• Title: Saima Karim, DO
• Organization: The University of Toledo

Saima.Karim@utoledo.edu

419-383-3697

Study Officials

• Jennifer Cummings, MD

  The University of Toledo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2015
• First Posted: March 9, 2015
• Study Start: March 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: May 1, 2015
• Last Updated: October 7, 2019
• Results First Posted: October 7, 2019

Record last verified: 2019-09

Locations

US (1)