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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02574949
Other study ID # 15-8832-AE
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 26, 2015
Last updated October 13, 2015
Start date July 2015
Est. completion date July 2016

Study information

Verified date October 2015
Source University Health Network, Toronto
Contact Divyesh Sharma, MSc,MRCP
Phone 001-647-961-9336
Email divyeshsharma11@gmail.com
Is FDA regulated No
Health authority Canada: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

Minimizing radiation exposure to patient and the operator is considered one of the primary safety concerns in the catheterization laboratory. Patients undergoing diagnostic angiography +/- ad hoc PCI or planned PCI, will be randomised to conventional settings (15 FPS and 15 PPS) or low frame rate settings (7.5 FPS and 15 PPS) or low Cine settings (7.5 FPS and 10 PPS). The patient radiation dose, patient radiation dose area product (DAP), and fluoroscopy time will be measured.

Statistical Analysis:

Demographic and procedural variables will be presented as percentage (categorical variable) or mean ± SD (continuous variable). Patients will be randomized into three arms - a control arm and two intervention arms. The angiographic radiation protocol will adhere to standard practice in both fluoroscopy and cine images at 15 frames/second. The intervention arm will consist of two groups. Group 1 with fluoroscopy images set at 7.5 frames/second and cine images set at 15 frames/second and group 2 with fluoroscopy set at 7.5 frames/second and cine set at 10 frames/second.

Sample size calculations are based on assuming a reduction in radiation dose in group 1 of 10% and in group 2 of 20%. At 5% significance and 80% power, a sample size of 200 patients will be required in each intervention arm. Allowing for a 10% attrition rate, a sample size of 220 patients will be required in each intervention arm with 100 patients in the control arm.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 600
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Intervention

Radiation:
Radiation: 15 FPS Cine 15 PPS
Radiation 15 FPS Cine 15 PPS
Radiation: 7.5 low Frame rate
Radiation: Frame rate 7.5 FPS, Cine 15 PPS
Low Cine
Radiation: Frame rate 7.5 FPS, Cine 10 PPS

Locations

Country Name City State
Canada University Health Network - Peter Munk Cardiac Centre Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Radiation Exposure to patient Radiation exposure to patient will be measured by Dose-Area product (DAP) collected during the procedure. During Cardiac catheterization procedure Yes
Secondary Image quality assessment of the coronary angiogram Coronary angiograms will be assessed by blinded operators for quality of image using a pre-specified tool 12 months No
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