ROI Fluoroscopy for Cardiovascular Disease

Phase 1

Waitlist Available

Led By Alexander J Dick, MD

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is greater than 18 years of age

Be older than 18 years old

Must not have

Subject requires urgent/emergent cardiac catheterization, PCI, and/or EP procedures as per treating physician

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effects of two types of fluoroscopy on patients during cardiac interventions. It is predicted that the attenuated x-rays will reduce exposure and risk without compromising image quality.

Who is the study for?

This trial is for adults over 18 who need routine heart procedures like catheterization, coronary interventions, or electrophysiology ablations. Participants must be able to follow the study's process and have given informed consent. Pregnant individuals or those needing urgent heart procedures are excluded.

What is being tested?

The study tests a new X-ray technique called Region-of-Interest Imaging against standard fluoroscopy in cardiac procedures. The goal is to see if it reduces radiation exposure without losing image quality needed for diagnosis.

What are the potential side effects?

Since this trial focuses on imaging techniques rather than medications, side effects may include potential risks associated with reduced image clarity leading to diagnostic inaccuracies but not typical drug-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I need an urgent heart procedure as advised by my doctor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 2Experimental Treatment1 Intervention

Subjects undergoing routine cardiac catheterization or interventional procedures using the region-of-interest fluoroscopy (x-ray fovea imaging) system.

Group II: 1Active Control1 Intervention

Subjects undergoing routine cardiac catheterization or interventional procedures using the standard fluoroscopy system.

0 / 2Eligibility criteria met