Computed Tomography and Biomarker Analysis in Diagnosing Coronary Artery Disease in Asymptomatic Patients Who Have Undergone Stem Cell Transplant
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer, High Blood Pressure (Hypertension), Peripheral Vascular Disease, Cardiology, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology, Oncology |
| Healthy: | No |
| Age Range: | 45 - Any |
| Updated: | 4/13/2015 |
| Start Date: | February 2014 |
Assessment of Coronary Artery Disease in Asymptomatic Survivors of Allogeneic Hematopoietic Cell Transplantation (HCT): A Pilot Feasibility Study
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.
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.
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).
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).
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
We found this trial at
1
site
1500 East Duarte Road
Duarte, California 91010
Duarte, California 91010
626-256-HOPE (4673)
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