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

Study Overview
=================
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.

Detailed 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.

Official Title
-----------------
Impact of Low Frame Rate Fluoroscopy and Cine-angiography on Reducing Operator and Patient Radiation Dose and Impact on Image Quality During Cardiac Catheterization

Conditions
-----------------
Stable Angina, Unstable Angina, Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Radiation: Radiation: 15 FPS Cine 15 PPS
* Radiation: Radiation: 7.5 low Frame rate
* Radiation: Low Cine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional rate fluoroscopy<br>Radiation: 15 FPS Cine 15 PPS | Radiation: Radiation: 15 FPS Cine 15 PPS<br>* Radiation 15 FPS Cine 15 PPS<br>* Other names: Conventional;|
| Experimental: Intermediate frame rate 7.5 fps<br>Radiation: 7.5 low Frame rate | Radiation: Radiation: 7.5 low Frame rate<br>* Radiation: Frame rate 7.5 FPS, Cine 15 PPS<br>* Other names: Low rate fluoroscopy;|
| Experimental: Low frame rate<br>Low Cine 10 PPS | Radiation: Low Cine<br>* Radiation: Frame rate 7.5 FPS, Cine 10 PPS<br>* Other names: Low pulse rate Cine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radiation, fluoroscopy, diagnostic