Impact of Low Frame Rate Fluoroscopy and Cine-angiography on Reducing Operator and Patient Dose

NCT02574949 | Unknown

• 1 other identifier: 15-8832-AE
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators sought to investigate the efficacy of low frame rate (fluoroscopy at 7.5 frames per second (FPS) and Cine at 10 pulse per second (PPS) vs. conventional (15 FPS and 15 PPS) on radiation dose to the patient and the operator during coronary angiography and intervention. In addition, investigators sought to qualitatively assess the effect, if any, of the low frame rate on angiographic image quality.

Conditions

Stable Angina; Unstable Angina; Acute Coronary Syndrome

Keywords

radiation; fluoroscopy; diagnostic

Outcome Measures

Primary Outcomes (1)

• Radiation Exposure to patient

  Radiation exposure to patient will be measured by Dose-Area product (DAP) collected during the procedure.

  During Cardiac catheterization procedure

Secondary Outcomes (1)

• Image quality assessment of the coronary angiogram

  12 months

Study Arms (3)

Conventional rate fluoroscopy

ACTIVE COMPARATOR

Radiation: 15 FPS Cine 15 PPS

Radiation: Radiation: 15 FPS Cine 15 PPS

Intermediate frame rate 7.5 fps

EXPERIMENTAL

Radiation: 7.5 low Frame rate

Radiation: Radiation: 7.5 low Frame rate

Low frame rate

EXPERIMENTAL

Low Cine 10 PPS

Radiation: Low Cine

Interventions

Radiation: 15 FPS Cine 15 PPS RADIATION

Radiation 15 FPS Cine 15 PPS

Also known as: Conventional

Conventional rate fluoroscopy

Radiation: 7.5 low Frame rate RADIATION

Radiation: Frame rate 7.5 FPS, Cine 15 PPS

Also known as: Low rate fluoroscopy

Intermediate frame rate 7.5 fps

Low Cine RADIATION

Radiation: Frame rate 7.5 FPS, Cine 10 PPS

Also known as: Low pulse rate Cine

Low frame rate

Eligibility Criteria

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

You may qualify if:

• Patients undergoing elective or urgent cardiac catheterisation with or without ad-hoc PCI or planned PCI in the pre-specified catheterisation laboratories.

You may not qualify if:

• Patients who undergo procedures other than diagnostic coronary angiography or intervention (e.g. electrophysiological procedures).
• Patients participating in other research study requiring higher cine angiography.
• ST-elevation Myocardial Infarction

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network - Peter Munk Cardiac Centre

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Angina, Stable; Angina, Unstable; Acute Coronary Syndrome; Disease

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Vladimir Dzavik, MD, FRCPC

  UHN, Toronto, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Divyesh Sharma, MSc,MRCP

CONTACT

001-647-961-9336; divyeshsharma11@gmail.com

Ashish H Shah, MD, MD(Res)

CONTACT

001-416-835-2822; ashish.shah@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research and Innovation-Interventional Cardiology and Coronary Intensive Care Unit

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: October 14, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 14, 2015

Record last verified: 2015-10

Locations

CA (1)