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

NCT00817115 | Unknown Phase 1

• 1 other identifier: 005-2008
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the proposed study is to compare the exposure dose and diagnostic performance of region-of-interest fluoroscopy compared to standard fluoroscopy in patients and interventionists during cardiac interventional procedures. It is hypothesized that systematic application of x-ray attenuation will significantly reduce the radiation exposure of the interventional procedure while maintaining image quality, thereby decreasing risk to the patient.

Conditions

Cardiovascular Diseases

Keywords

Region-of-Interest Imaging; X-ray Fovea Imaging; Cardiovascular Diseases; Radiation Dosage; Radiographic Image Enhancement; Radiography, Interventional

Outcome Measures

Primary Outcomes (1)

• X-ray exposure area product, primary and scatter radiation to patient and interventionist and procedure and irradiation time for interventions performed without and with region-of-interest imaging (control and experimental arms, respectively).

  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).

Secondary Outcomes (1)

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

  Retrospective expert comparison of images from patient procedures (between control and experimental arms) will occur within 1 to 3 months after the completion of the pilot study and the full study.

Study Arms (2)

1

NO INTERVENTION

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

2

EXPERIMENTAL

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

Device: Region-of-Interest Imaging (X-ray Fovea Imaging)

Interventions

Region-of-Interest Imaging (X-ray Fovea Imaging) DEVICE

Use of an experimental fluoroscopy system fitted with a region-of-interest attenuator (fovea) to evaluate or treat lesions during cardiac interventional procedures.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is greater than 18 years of age.
• The subject is currently planned for conventional cardiac interventional procedures (i.e. catheterization, percutaneous coronary intervention (PCI), electrophysiology (EP) ablations and procedures) as specified by his/her physician.
• The subject is able and willing to comply with study procedures, and signed and dated informed consent is obtained.

You may not qualify if:

• The subject is pregnant or trying to become pregnant.
• The subject requires urgent/emergent cardiac catheterization, PCI, and/or EP procedures as per treating physician.
• The subject has been previously included in the study.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• General Electric: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Alexander J Dick, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Normand Robert, PhD

  Sunnybrook Health Sciences Centre

  STUDY DIRECTOR

• John A Rowlands, PhD

  Sunnybrook Health Sciences Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 14, 2008
• First Posted: January 6, 2009
• Study Start: February 1, 2009
• Primary Completion: December 1, 2009
• Last Updated: August 7, 2009

Record last verified: 2009-01

Locations

CA (1)