Radiation Dose Reduction Using Advanced Fluoroscopy Options in Coronary Cath Lab
1 other identifier
interventional
480
1 country
1
Brief Summary
Fluoroscopy is integral part of diagnostic and therapeutic cardiac procedures. Among medical personnel, interventional cardiologists have the highest per head per year exposure to ionizing radiation which is two to three times greater than the radiologists. Although the patients' exposure is well below the level associated with increased cancer risk, yet as mentioned above, any exposure can be harmful and must be minimized using all possible dose reduction methods under the principle of 'As Low as Reasonably Achievable' (ALARA). Radiation exposure is influenced by factors that are dependent on patient (weight, body habitus), procedure (access site, procedure complexity, use of protective shielding, collimation) and equipment (overall quality control, field of view, beam filters thickness, pulse rate etc.). In fact in modern fluoroscopic equipment, several settings are customizable to aid reduce total emitted X-ray dose. In a diverse coronary lab as Tabba Heart institute, in addition to training the lab staff on reducing radiation exposure and use of protective gear, employment of a modern X ray system Like Toshiba (Infinix i8000V, Toshiba America Medical Systems, Inc.); equipped with customizable radiation dose reduction technologies and DTS, provides the interventionists an essential tools to ensure the highest radiation safety standards. Data is still scanty to show the difference in patients and operators' radiation exposures by using tailored equipment settings. We aim to apply customized fluoroscopy protocols based on low fps and other customizable settings (thickness of the spectral beam filters, peak tube voltage and peak cathode current, live zoom (1.4 factors with 12 inch FOV), fluoro store and Spot fluoroscopy) and then assess if they significantly affect the radiation exposure of the patient and the interventionist.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2020
CompletedFirst Posted
Study publicly available on registry
May 15, 2020
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2021
CompletedMay 15, 2020
May 1, 2020
6 months
May 12, 2020
May 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
patient and operator radiation exposure
Operator dose (μSv): Exposure of X-ray to the first and second operator will be measured using the Raysafe i2 system (Unfors Raysafe, Sweden). The personal dosimeter (PDM) in this consists of semiconductors layered with a film and provides real time dose information. All operators will wear the PDM on left side on upper torso. PDM readings will be obtained on an individual procedure basis and readings will be hidden from the operators. Patient total X-ray dose: This will be calculated by obtaining adjusted mean total x-ray dose i.e. air kerma (Gy), dose area product (DAP) (Gy/cm2) and real time Peak skin dose in mGy using Toshiba Inc.'s dose tracking system.
within 24 hours
Secondary Outcomes (1)
quality of imaging
within 24 hours
Study Arms (3)
Standard Protocol
ACTIVE COMPARATORThis is the fluoroscopy protocol used routinely in most catheterization labs in the region. This includes fluoroscopy and cine image acquisition at 15 frames per second (FPS) at 8-inch mode. Virtual collimation and last image hold (LIH) will be used as needed. This protocol will be implemented for 6 weeks.
Low frame rate protocol
EXPERIMENTALThis will have fluoroscopy and cine image acquisition at 7.5 FPS at 8-inch mode with all other settings on factory default. Virtual collimation and LIH will be used as needed. This protocol will be implemented for 6 weeks as well.
Customized Protocol
EXPERIMENTALThis will have varying settings based on three weight based groups. Small (\<60 kg), medium (60-85 kg), large (\>85 kg). The variables changed are fluoroscopy dose per frame, fluoroscopy frame rate, image acquisition frame rate, thickness of the spectral beam filters, peak tube voltage and peak cathode current. Additional features will also be utilized including live zoom (1.4 factors with 12 inch field of view, FOV), fluoro store and Spot fluoroscopy. Virtual collimation and LIH will be used as needed. This protocol will be applied for 12 weeks.
Interventions
X-ray radiation is routinely used for imaging in coronary cath labs. Intervention involves lowering patient and operators X-ray exposure by employing various setting on the fluoroscopy machine.
Eligibility Criteria
You may qualify if:
- percutaneous coronary interventional (PCI) and other fluoroscopy assisted cardiac procedures including valvular interventions and device closures.
- Both emergent and elective procedures.
- Patients undergoing procedures both via trans-radial or trans-femoral approach will be included.
You may not qualify if:
- Intra-cardiac device insertions and procedures requiring digital subtraction angiography (DSA) will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tabba Heart Institute
Karachi, Sindh, 75950, Pakistan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Asad Z Pathan, MD
Tabba Heart Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2020
First Posted
May 15, 2020
Study Start
July 1, 2020
Primary Completion
December 31, 2020
Study Completion
March 31, 2021
Last Updated
May 15, 2020
Record last verified: 2020-05