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OpenTrials
Completed

NCT Number: NCT05949138

Clinical Data Collection and Evaluation of ECG-Less Cardiac CT

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.

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Key information

Conditions

Cardiac CT

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Chicago, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

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.

Primary outcomes

  1. Data Collection

    Time frame: Through study completion, an average of 6 months

    Number of Participants with raw investigational cardiac CT scan data

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Collaborators

  • University of Chicago
  • University of Washington

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 17, 2023
Registry last updated
Jun 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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