Clinical Comparison of Electrocardiograms Collected Using an Ambulatory Holter

NCT ID: NCT02383667

Last Updated: 2019-10-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Electrocardiography

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Electrocardiogram holter

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Patients who cannot wear a Holter monitor
* Patients undergoing an MRI or have other contraindications for wearing an ambulatory Holter monitor.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Toledo Health Science Campus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jennifer Cummings, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Toledo

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Toledo, Health Science Campus

Toledo, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Orbital

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.