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

NCT01890525 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2019-12-06

No results posted yet for this study

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

Sponsors & Collaborators

Principal Investigators

  • James J Jang, MD · Kaiser Permanente

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-01
Primary Completion
2016-08-15
Completion
2019-10-15

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01890525 on ClinicalTrials.gov