Computed Tomography and Biomarker Analysis in Diagnosing Coronary Artery Disease in Asymptomatic Patients Who Have Undergone Stem Cell Transplant

City of Hope

Status

Completed

Conditions

Hypertension

Diabetes Mellitus

Cancer Survivor

Treatments

Other: laboratory biomarker analysis

Other: questionnaire administration

Procedure: computed tomography

Other: cytology specimen collection procedure

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02077218

13385 (Other Identifier)

NCI-2014-00419 (Registry Identifier)

Details and patient eligibility

About

This pilot clinical trial studies computed tomography (CT) scans and biomarker analysis in diagnosing coronary artery disease (CAD) in patients who have undergone a stem cell transplant but have no symptoms of CAD. CAD is a disease in which there is a narrowing or blockage of the coronary arteries (blood vessels that carry blood and oxygen to the heart) and patients who have undergone a stem cell transplant are at an especially high risk for CAD. A CT scan involves a series of detailed pictures of areas inside the body taken from different angles. The pictures are created by a computer linked to an x-ray machine. Studying samples of blood from patients who have undergone a stem cell transplant in the laboratory may help doctors identify and learn more about biomarkers related to CAD. Using a CT scan in combination with biomarker analysis may be a better and less-invasive way to diagnose CAD.

Full description

PRIMARY OBJECTIVES:

I. Evaluate the feasibility of using CT-based imaging and blood biomarkers for assessment of asymptomatic coronary artery disease (CAD) in survivors of allogeneic hematopoietic stem cell transplant (HCT).

SECONDARY OBJECTIVES:

I. Determine the prevalence and severity of asymptomatic CAD, as measured by CT angiography.

II. Describe the association between patient demographics (age, sex, race/ethnicity), pre-HCT chest radiation, HCT-related exposures (total body irradiation [TBI], conditioning chemotherapy), graft-versus-host disease (GvHD) and its management and cardiovascular risk factors (CVRFs) on extent of CAD.

III. Describe the association between asymptomatic CAD and candidate blood biomarkers of vessel injury and inflammation (high-sensitivity C-reactive protein [hs-CRP], lipoprotein-associated phospholipase A2 [Lp-PLA2]).

OUTLINE:

Patients undergo cardiac CT and collection of blood samples for analysis of hs-CRP via quantitative immunoturbidimetry and Lp-PLA2 via enzyme-linked immunosorbent assay (ELISA).

Enrollment

20 patients

Sex

All

Ages

45+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Alive and in complete remission at time of enrollment
Underwent allogeneic HCT after 1995
Time between HCT and study entry: >= 2 years
Have at least one CVRF (hypertension, diabetes, dyslipidemia) at the time of eligibility determination

Exclusion criteria

History of ischemic heart disease, stroke, or cardiomyopathy/congestive heart failure
Abnormal renal function (glomerular filtration rate [GFR] < 60 mL/min/1.73m2)
Pregnancy
Known allergy to intravenous (IV) contrast
Sustained or symptomatic ventricular dysrhythmias uncontrolled with drug therapy or implantable device; significant conduction defects (i.e.: second or third degree atrioventricular block or sick sinus syndrome)
Current clinical evidence of moderate-to-severe obstructive pulmonary disease or reactive airway diseases (i.e.: asthma) requiring therapy
History of drug sensitivity or allergic reaction to beta-blockers
Currently taking calcium channel blockers such as verapramil and diltiazem
History of unrepaired severe aortic stenosis