Clinical trial NCT02077218: Computed Tomography and Biomarker Analysis in Diagnosing Coronary Artery Disease in Asymptomatic Patients Who Have Undergone Stem Cell Transplant
Official title: Assessment of Coronary Artery Disease in Asymptomatic Survivors of Allogeneic Hematopoietic Cell Transplantation (HCT): A Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivor
Diabetes Mellitus
Hypertension
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-03-04
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility, defined by the percentage of patients that enroll onto the study, successful completion of all study measurements, ability of studies to be interpreted, and achievement of the recruitment goal
timeFrame: Up to 9 weeks
Secondary outcomes:
Other outcomes:
measure: Prevalence of asymptomatic CAD, as measured by CT angiography
timeFrame: Up to 9 weeks
measure: Severity of asymptomatic CAD, as measured by CT angiography
timeFrame: Up to 9 weeks
measure: Patient demographics (age, sex, race/ethnicity)
timeFrame: Up to 9 weeks
measure: Pre-HCT chest radiation
timeFrame: Up to 9 weeks
measure: HCT-related exposures (TBI, conditioning chemotherapy)
timeFrame: Up to 9 weeks
measure: Management of GvHD
timeFrame: Up to 9 weeks
measure: CVRF-specific characteristics
timeFrame: Up to 9 weeks
measure: Expression of hs-CRP
timeFrame: Up to 9 weeks
measure: Expression of Lp-PLA2
timeFrame: Up to 9 weeks
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Saro Armenian
role: PRINCIPAL_INVESTIGATOR
References: