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Clinical Data Collection and Evaluation of ECG-Less Cardiac CT

NCT05949138 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 56

Last updated 2024-06-07

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Kayla Matcheck · GE Healthcare

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-11
Primary Completion
2023-11-01
Completion
2023-11-03
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05949138 on ClinicalTrials.gov