PROMISE Substudy to Assess For Effective Dose of Radiation (PROMISE-SAFER) Specific Aim 3b
The purpose of this study is to compare different methods of collecting the amount of radiation exposure patients receive in a clinical study. As part of the PROMISE study, the Duke Clinical Research Institute Outcomes and Follow-up Group will be contacting patients every six months to ask if they had any heart procedures or testing. This information will be used to estimate the amount of radiation that they may have received from heart testing being studied in this study, PROMISE-SAFER. Patients will be asked to collect information about each heart testing they receive during the time that they are enrolled in the PROMISE study. At the conclusion of the study, we will be able to determine which method was most accurate in collecting the amount of radiation exposure for this clinical study. Through this study we hope to develop an improved methodology to estimate cumulative radiation exposure from cardiac imaging. Comprehensive measurement of cumulative radiation exposure to patients may be critically important to minimize potential harm in future studies and in clinical practice.
Coronary Artery Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||PROMISE Substudy to Assess For Effective Dose of Radiation (PROMISE-SAFER), Specific Aim 3b|
- Methods to measure cumulative radiation exposure from a cardiac imaging trial will be compared to radiation measurements from the "gold standard" electronic medical records [ Time Frame: 4 years ] [ Designated as safety issue: No ]In a single site (San Jose Medical Center - Kaiser Permanente) at a health maintenance organization where patients undergo all testing on site and comprehensive radiation records are maintained, 3 approaches to obtaining follow-up radiation dosimetry estimates will be compared: 1) the standard method used at all sites of combining those procedures identified on follow-up surveys with measured or imputed procedure dose estimates, 2) Radiation Log forms that patients will receive and will be asked to complete whenever they undergo further imaging, and 3) "gold standard" review of patient electronic medical records to identify all procedures with ionizing radiation and measured dose estimates from each procedure.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
|PROMISE study patients|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01890525
|United States, California|
|San Jose Medical Center - Kaiser Permanente|
|San Jose, California, United States, 95119|
|Principal Investigator:||James J Jang, MD||Kaiser Permanente|