NCT01890525

PROMISE Substudy to Assess For Effective Dose of Radiation (PROMISE-SAFER) Specific Aim 3b

PROMISE Substudy to Assess For Effective Dose of Radiation (PROMISE-SAFER), Specific Aim 3b

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chest Pain
• Coronary Artery Disease
• Angina

Timeline

• Start date: 2012-08-01
• Primary completion: 2016-08-15
• Completion: 2019-10-15
• First posted: 2013-07-01
• Last updated: 2019-12-06

Locations

1 site across 1 country: United States