NCT02077218

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

Assessment of Coronary Artery Disease in Asymptomatic Survivors of Allogeneic Hematopoietic Cell Transplantation (HCT): A Pilot Feasibility Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Accepted

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).

Conditions

• Cancer Survivor
• Diabetes Mellitus
• Hypertension

Interventions

Type	Name	Description
PROCEDURE	computed tomography	Undergo cardiac CT
OTHER	cytology specimen collection procedure	Undergo collection of blood samples
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	questionnaire administration	Ancillary studies

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2014-03-04
• Last updated: 2015-04-21

Locations

1 site across 1 country: United States