Clinical Data Collection and Evaluation of ECG-Less Cardiac CT

Completed

• Conditions: Cardiac CT
• Interventions: Device: ECG-Less Cardiac CT using SmartPhase

• Registration Number: NCT05949138
• Lead Sponsor: GE Healthcare

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.

Detailed Description

Data collected in this study will be used for technology development, scientific evaluation, marketing and education, and regulatory submissions for future products. This is a pre-market, prospective, open-label, non-randomized, single arm data collection clinical study conducted at one site in the United States of America.

Study Timeline

• Study First Submitted: 2023-06-14
• Study First Submitted QC: 2023-07-14
• Study First Posted: 2023-07-17
• Study Start: 2023-09-11
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-03
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Subjects may be included in this study if they meet the following criteria:

1. Who are 18 year of age or older;
2. Able to sign and date the informed consent form; AND
3. Who are scheduled for a clinical-indicated Cardiac CT exam that will include contrast administration.

Exclusion Criteria

Subjects may be excluded from participating in study if they meet any of the following criteria:

1. Who are pregnant or lactating;
2. Who were previously enrolled in this study;
3. Anyone with known or suspected allergy to iodinated contrast agents;
4. Anyone with known or suspected renal insufficiency as determined by site medical personnel;
5. Who are scheduled for a CT cardiac calcium scoring test;
6. Who are in need of urgent or emergent care;
7. 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
8. Who are unwilling to have GEHC personnel present for the CT exam.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ECG-Less Cardiac CT	ECG-Less Cardiac CT using SmartPhase	Enrolled subjects will receive a clinically-indicated, diagnostic Cardiac CT with contrast. No ECG leads will be applied.

Primary Outcome Measures

Name	Time	Method
Data Collection	Through study completion, an average of 6 months	Number of Participants with raw investigational cardiac CT scan data

Trial Locations

Locations (2)

University of Washington; 🇺🇸 Seattle, Washington, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States