Clinical Data Collection and Evaluation of ECG-Less Cardiac CT

NCT05949138 | Completed FDA Device

• 1 other identifier: 11771729874
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of this study is to collect CT scan data without ECG-leads attached to the human subject. This data is intended to represent a typical range of clinical scenarios in which Cardiac CT imaging is used.

Conditions

Cardiac CT

Outcome Measures

Primary Outcomes (1)

• Data Collection

  Number of Participants with raw investigational cardiac CT scan data

  Through study completion, an average of 6 months

Study Arms (1)

ECG-Less Cardiac CT

Enrolled subjects will receive a clinically-indicated, diagnostic Cardiac CT with contrast. No ECG leads will be applied.

Device: ECG-Less Cardiac CT using SmartPhase

Interventions

ECG-Less Cardiac CT using SmartPhase DEVICE

Administration of medications and biologic products (such as contrast agent administration, and potentially beta-blockers and other medications) will be given according to standard hospital care. This is a prospective research study evaluating an investigational workflow on an existing CT device that has regulatory clearance. The investigational workflow includes preforming the CT acquisition according to the hospital's usual care with the exception that the ECG signal which triggers the scan will be coming from an ECG simulator based on an estimate of the patient's heart rate, rather than through ECG leads connected to the subject. Clinically-indicated Cardiac CTs take approximately 30-60 minutes. No additional imaging is needed as part of the study.

ECG-Less Cardiac CT

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

The subject population will consist of adults that are 18-years of age or older, and who are scheduled for a clinically indicated cardiac CT exam that will include contrast administration.

You may qualify if:

• Subjects may be included in this study if they meet the following criteria:
• Who are 18 year of age or older;
• Able to sign and date the informed consent form; AND
• Who are scheduled for a clinical-indicated Cardiac CT exam that will include contrast administration.

You may not qualify if:

• Subjects may be excluded from participating in study if they meet any of the following criteria:
• Who are pregnant or lactating;
• Who were previously enrolled in this study;
• Anyone with known or suspected allergy to iodinated contrast agents;
• Anyone with known or suspected renal insufficiency as determined by site medical personnel;
• Who are scheduled for a CT cardiac calcium scoring test;
• Who are in need of urgent or emergent care;
• Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the subject; AND
• Who are unwilling to have GEHC personnel present for the CT exam.

Sponsors & Collaborators

• GE Healthcare: lead
• University of Chicago: collaborator
• University of Washington: collaborator

Study Sites (2)

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Study Officials

• Kayla Matcheck

  GE Healthcare

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: July 17, 2023
• Study Start: September 11, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 3, 2023
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)