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NCT01890525 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Kaiser Permanente.

Completed
Registry status
20
Enrollment target

NCT01890525: Completed study, sponsored by Kaiser Permanente.

NCT01890525 is a clinical trial that has completed, run by Kaiser Permanente. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01890525 has completed, sponsored by Kaiser Permanente.

COMPLETED
Registry status
20 participants
Enrollment target

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.

Primary Outcome

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

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2012-08-01
Est. Completion 2019-10-15
Kaiser Permanente

294 total trials

What the finished NCT01890525 record still lists

NCT01890525 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT01890525 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01890525 about?

NCT01890525 is a clinical study titled "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 h...

What is the current status of trial NCT01890525?

This trial is currently completed. The enrollment target is 20 participants. The study started on 2012-08-01. Estimated completion is 2019-10-15.

Who is sponsoring clinical trial NCT01890525?

This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01890525, the US trial registry maintained by the National Library of Medicine. NCT01890525 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.