50 Participants Needed

GSI Cardiac Scan for Coronary CT Angiography

MC
Overseen ByMelissa Challman
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: GE Healthcare
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new CT scan method for heart health, using technology on GE HealthCare's Revolution Apex CT system. Participants will be divided into two groups: one group will receive a Coronary CT Angiography (a detailed heart scan), and the other group includes individuals with a history of heart attacks or those undergoing heart catheterization (a procedure to check heart blood flow). Those scheduled for a heart scan or who have had a heart attack might be suitable for this trial. Participation requires involvement for about one day.

As an unphased study, this trial provides a unique opportunity to contribute to advancing heart health technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the GSI Cardiac Scan is safe for coronary CT angiography?

Research shows that coronary CT angiography (CCTA), similar to the GSI Cardiac scan, is generally safe and easy for patients to handle. Studies have found that CCTA uses less radiation than other tests, such as nuclear stress testing, making it a safer option for many people.

Other research indicates that CCTA is a non-invasive and effective way to assess heart health in individuals who might have heart problems, offering a good alternative to more invasive procedures. The GSI Cardiac scan aims to gather information using a new CT system. Although specific safety data for the GSI mode is not yet available, the similar CCTA procedure has a history of safety.

Overall, evidence suggests that the GSI Cardiac scan should be easy to tolerate, with a low risk of side effects based on knowledge of similar scans.12345

Why are researchers excited about this trial?

Researchers are excited about the GSI Cardiac on Revolution Apex trial because it is evaluating innovative cardiac imaging techniques that could revolutionize how heart conditions are diagnosed. Unlike current methods, which often rely on invasive procedures like cardiac catheterization, this trial explores the potential of advanced cardiac computed tomography angiography (CCTA) to provide detailed heart images non-invasively. This could lead to quicker, safer, and more accurate assessments of heart health, especially in patients with a history of heart attacks or known coronary disease. By enhancing the imaging process, the study aims to improve early detection and treatment planning, paving the way for better patient outcomes.

What evidence suggests that the GSI Cardiac Scan is effective for coronary CT angiography?

Research has shown that Coronary CT Angiography (CCTA) effectively diagnoses heart problems, particularly in individuals with stable chest pain. It surpasses other tests in detecting and ruling out blocked heart arteries. This trial tests the GSI Cardiac scan, a new method alongside CCTA, using advanced imaging techniques to potentially enhance clarity and accuracy. Although specific data on the GSI Cardiac scan's effectiveness is still being collected, advancements in imaging technology suggest it could offer more reliable heart issue diagnoses. Early results indicate it might deliver better image quality with reduced radiation.13678

Who Is on the Research Team?

BT

Brian Thomsen

Principal Investigator

GE Healthcare

Are You a Good Fit for This Trial?

Inclusion Criteria

I can sign and understand the consent form.
I am scheduled for a CCTA as part of my clinical care.
I have had a heart attack or need a heart procedure due to heart disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Data Collection

Participants undergo CT scans using the GSI Cardiac mode on the Revolution Apex CT system

1 day
1 visit (in-person)

Safety Monitoring

Participants are monitored for adverse events over a 12-month period

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • GSI Cardiac Scan

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Cohort BExperimental Treatment2 Interventions
Group II: Cohort AExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

GE Healthcare

Lead Sponsor

Trials
307
Recruited
634,000+
Fotis Vlachos profile image

Fotis Vlachos

GE Healthcare

Chief Marketing Officer since 2024

PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania

Peter J. Arduini profile image

Peter J. Arduini

GE Healthcare

Chief Executive Officer since 2022

MBA from Northwestern University, BSc in Marketing from Susquehanna University

University of Washington

Collaborator

Trials
1,858
Recruited
2,023,000+

Citations

NCT06702917 | GSI Cardiac on Revolution Apex - US

The goal of this clinical data collection study is to collect raw CT scan data using a new GSI Cardiac mode on GE HealthCare's Revolution Apex CT system.

Comparative Effectiveness of Coronary CT Angiography and ...

The pooled data showed a reduction of 14% (95% CI: 5%, 22%) in LOS for the CCTA arm compared with SOC arm (Fig 2). In group 1, considering the ...

First experience with monochromatic coronary computed ...

The aim of the study was to evaluate the optimal combination of monochromatic image energy and adaptive statistical iterative reconstruction (ASiR) for ...

The effectiveness of coronary computed tomography ...

In patients with stable chest pain, CTA is more effective than functional testing for the diagnosis as well as for reliable exclusion of obstructive CAD.

Feasibility study of 'Triple-Low' technique for coronary ...

This study aims to explore the feasibility of applying the “Three-Low” technique (low injection rate, low iodine contrast volume, low radiation dose) in ...

Safety of Coronary CT Angiography and Functional Testing ...

Compared to nuclear stress testing, CTA's lower radiation dose, independent of patient characteristics, makes it an attractive test choice. Radiation dose ...

Efficacy and safety of coronary computed tomography ...

The strategy employing coronary CTA is an effective and safe, non-invasive, outpatient-based alternative to ICA for patients with a high clinical likelihood of ...

Selecting a CT scanner for cardiac imaging: the heart of ...

Coronary angiography to assess the presence and degree of arterial stenosis is an examination now routinely performed on CT scanners.