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Radiation

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the outcome measure will be recorded per patient procedure. a comparison between control and experimental arms will be conducted after the pilot study (at ~1 to 2 months) and at end the full study (at ~4 to 6 months).

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the outcome measure will be recorded per patient procedure. a comparison between control and experimental arms will be conducted after the pilot study (at ~1 to 2 months) and at end the full study (at ~4 to 6 months).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the outcome measure will be recorded per patient procedure. a comparison between control and experimental arms will be conducted after the pilot study (at ~1 to 2 months) and at end the full study (at ~4 to 6 months).

This trial's timeline: 3 weeks for screening, Varies for treatment, and the outcome measure will be recorded per patient procedure. a comparison between control and experimental arms will be conducted after the pilot study (at ~1 to 2 months) and at end the full study (at ~4 to 6 months). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Diagnostic Imaging

Secondary outcome measures

Quality and diagnostic benefit of images obtained without and with the region-of-interest imaging.

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,550,547 Total Patients Enrolled

General ElectricIndustry Sponsor

46 Previous Clinical Trials

12,322 Total Patients Enrolled

John A Rowlands, PhDStudy ChairSunnybrook Health Sciences Centre

Media Library

Region-of-Interest Imaging (X-ray Fovea Imaging) (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT00817115 — Phase 1

Cardiovascular Disease Research Study Groups: 1, 2

Cardiovascular Disease Clinical Trial 2023: Region-of-Interest Imaging (X-ray Fovea Imaging) Highlights & Side Effects. Trial Name: NCT00817115 — Phase 1

Region-of-Interest Imaging (X-ray Fovea Imaging) (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00817115 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks do patients face when undergoing Region-of-Interest Imaging (X-ray Fovea Imaging)?

"Our team has assessed the safety of Region-of-Interest Imaging (X-ray Fovea Imaging) to be a 1, given that this is just a Phase 1 trial with limited data supporting efficacy and safety."

Answered by AI

Are volunteers able to enlist in this research initiative?

"This clinical trial is no longer actively recruiting participants, according to information on clinicaltrials.gov. Initially posted February 1st 2009 and last edited August 6th 2009, this study has closed its recruitment process but 414 other medical studies are presently welcoming patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of Exposure Reduction Using Region-of-Interest Fluoroscopy (X-ray Fovea Imaging) in Cardiac Interventions

2009. "Evaluation of Exposure Reduction Using Region-of-Interest Fluoroscopy (X-ray Fovea Imaging) in Cardiac Interventions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00817115.

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