Status:
COMPLETED
PROMISE Substudy to Assess For Effective Dose of Radiation (PROMISE-SAFER) Specific Aim 3b
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
Columbia University
Conditions:
Chest Pain
Coronary Artery Disease
Eligibility:
All Genders
45+ years
Brief 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 ...
Eligibility Criteria
Inclusion
- All patients who meet inclusion criteria and enroll in the parent PROMISE study will be eligible to participate in PROMISE-SAFER.
- New or worsening chest pain syndrome or equivalent symptoms suspicious for clinically significant coronary artery disease
- No prior evaluation for this episode of symptoms
- Planned non-invasive testing for evaluation of possible coronary artery disease
- Men age \> 55 and women age ≥65 years
- If age in men 45 - 54 or women 50 - 64 years, then must have increased probability of CAD due to EITHER:
- A. Diabetes Mellitus (DM) requiring medical treatment OR Peripheral Arterial Disease (PAD) defined as documented \>50% peripheral arterial stenosis treated medically or invasively OR Cerebrovascular disease (stroke, documented \> 50% carotid stenosis treated medically or invasively)
- OR
- B. At least one of the following cardiovascular risk factors:
- Ongoing tobacco use
- Hypertension
- Abnormal ankle-brachial index defined as less than \<0.9
- Dyslipidemia
- Serum creatinine \< 1.5 mg/dL within the past 90 days
- Negative urine/serum pregnancy test for female subjects of child-bearing potential and not breast-feeding
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 15 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01890525
Start Date
August 1 2012
End Date
October 15 2019
Last Update
December 6 2019
Active Locations (1)
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1
San Jose Medical Center - Kaiser Permanente
San Jose, California, United States, 95119