Home » Clinical Trials » Therapeutic Areas Therapeutic Areas: Musculoskeletal | Neurology | Cardiology/Vascular Diseases | Family Medicine Disease Category: Chest Pain Location: United States, FL
Trial Information
PROMISE PROspective Multicenter Imaging Study for Evaluation of Chest Pain
Patient Inclusion Criteria:
New or worsening chest-pain syndrome or equivalent symptoms suspicious for clinically significant Coronary Artery Disease
No prior cardiac evaluation for this episode of symptoms
Planned noninvasive testing for diagnosis
Men age greater than or equal to 55 years and women age greater than or equal to 65 years
If age in men 45-54 years or women 50-64 years, then must have increased probability of Coronary Artery Disease due to 1 or more of the following risk factors: Diabetes mellitus requiring medical treatment Peripheral arterial disease (PAD), defined as documented peripheral arterial stenosis greater than or equal to 50%, treated medically or invasively Cerebrovascular disease (stroke), defined as documented carotid stenosis greater than or equal to 50%, treated medically or invasively Ongoing tobacco use Hypertension Abnormal ankle-brachial index (ABI), defined as less than 0.9 Dyslipidemia
Serum creatinine less than or equal to 1.5 mg/dL within the past 90 days
Negative urine/serum pregnancy test for female subjects of childbearing potential
Patient Exclusion Criteria:
Diagnosed or suspected Acute Coronary Syndrome requiring hospitalization or urgent or emergent testing; elevated troponin or creatine kinase-myocardial band (CK-MB); outpatients who have completed a rule-out Acute Coronary Syndrome protocol are eligible provided they have negative biomarkers x 2 and a nondiagnostic or normal ECG.
Hemodynamically or clinically unstable condition (systolic blood pressure [BP] less than 90 mm Hg, severe atrial or ventricular arrhythmias, or persistent resting chest pain felt to be ischemic despite adequate therapy)
Known Coronary Artery Disease with prior clinical history of Myocardial Infarction, Percutaneous Coronary Intervention, coronary artery bypass graft (CABG) or any angiographic evidence of Coronary Artery Disease greater than or equal to 50% lesion in a major epicardial vessel
Any invasive coronary angiography or noninvasive anatomic or functional cardiovascular test for detection of Coronary Artery Disease, including Coronary Computed Tomography Angiogram and exercise ECG, within the previous 12 months (+/- 30 days); prior resting ECG and/or resting echocardiogram do not constitute an exclusion to participation
Known significant congenital, valvular (greater than or equal to moderate) or cardiomyopathic process (hypertrophic cardiomyopathy or reduced systolic left ventricular [LV] function [LV ejection fraction less than 40%]) that could explain cardiac symptoms
Contraindication to a Coronary Computed Tomography Angiogram, including, but not limited to: a. Allergy to iodinated contrast agent; b. Pregnancy;
Any other contraindications that would preclude performing a Coronary Computed Tomography Angiogram per local site practice, such as 1 or more of the following:
Inability to receive beta blockers if heart rate is greater than 65 beats per minute;
Agatston score greater than 800;
Body mass index (BMI) greater than 40;
Cardiac arrhythmia
Life expectancy less than 2 years
Unable to provide written informed consent or participate in long-term follow-up 2.c
Pablo Guzman, MD (HCH Site); Ricky Schneider, MD (Coral Springs Site)
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