PROMISE Substudy to Assess For Effective Dose of Radiation (PROMISE-SAFER) Specific Aim 3b
Completed
Conditions studied: Chest Pain, Coronary Artery Disease, Angina
In brief
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.
Key facts
- Study ID
- NCT01890525
- Run by
- Kaiser Permanente
- People needed
- 20
- Starts
- 2012-08-01
- Expected to finish
- 2019-10-15
- Last updated by the study team
- 2019-12-06
Who can join
Age: 45 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Diagnosed or suspected acute coronary syndrome requiring hospitalization or urgent or emergent testing; Elevated troponin or creatinine kinase-MB
- Hemodynamically or clinically unstable condition (systolic blood pressure < 90 mmHg, atrial or ventricular arrhythmias, or persistent resting chest pain felt to be ischemic despite adequate therapy)
- Known coronary artery disease with prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting or any angiographic evidence of coronary artery disease ≥50% lesion in a major epicardial vessel.
- Any invasive coronary angiography or non-invasive anatomic or functional cardiovascular test for detection of coronary artery disease, including coronary computed tomographic angiography and exercise electrocardiogram, within the previous twelve (12) months.
- Known significant congenital, valvular (> moderate) or cardiomyopathic process (hypertrophic cardiomyopathy or reduced systolic left ventricular function (left ventricular ejection fraction ≤ 40%)) which could explain cardiac symptoms.
- Contraindication to undergoing a coronary computed tomographic angiography, including but not limited to:
- a. Pregnancy or breastfeeding
- Life expectancy < 2 years
- Unable to provide written informed consent or participate in long-term follow-up
Where it is running
- San Jose Medical Center - Kaiser Permanente — San Jose, California, United States
Full record on ClinicalTrials.gov
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