Clinical Data Collection and Evaluation of ECG-Less Cardiac CT

Cardiac CT Clinical Trial

Official title:

Clinical Data Collection and Evaluation of ECG-Less Cardiac CT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05949138
• Other study ID #: 11771729874
• Status: Completed
• Start date: September 11, 2023
• Est. completion date: November 3, 2023

Study information

• Verified date: June 2024
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 3, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac CT

Intervention

Device:
• ECG-Less Cardiac CT using SmartPhase
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.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois
United States	University of Washington	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
GE Healthcare	University of Chicago, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data Collection	Number of Participants with raw investigational cardiac CT scan data	Through study completion, an average of 6 months