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

Not Applicable

Completed

• Conditions: Cancer Survivor; Diabetes Mellitus; Hypertension
• Interventions: Procedure: computed tomography; Other: cytology specimen collection procedure; Other: laboratory biomarker analysis; Other: questionnaire administration

• Registration Number: NCT02077218
• Lead Sponsor: City of Hope Medical Center

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).

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-28
• Study First Submitted QC: 2014-02-28
• Study First Posted: 2014-03-04
• Status Verified: 2015-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-17
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (CT and blood biomarkers)	computed tomography	Patients undergo cardiac CT and collection of blood samples for analysis of hs-CRP via quantitative immunoturbidimetry and Lp-PLA2 via ELISA.
Diagnostic (CT and blood biomarkers)	questionnaire administration	Patients undergo cardiac CT and collection of blood samples for analysis of hs-CRP via quantitative immunoturbidimetry and Lp-PLA2 via ELISA.
Diagnostic (CT and blood biomarkers)	cytology specimen collection procedure	Patients undergo cardiac CT and collection of blood samples for analysis of hs-CRP via quantitative immunoturbidimetry and Lp-PLA2 via ELISA.
Diagnostic (CT and blood biomarkers)	laboratory biomarker analysis	Patients undergo cardiac CT and collection of blood samples for analysis of hs-CRP via quantitative immunoturbidimetry and Lp-PLA2 via ELISA.

Primary Outcome Measures

Name	Time	Method
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	Up to 9 weeks	The current protocol will be considered feasible if: 1) \>= 30% of eligible patients that are approached for participation enroll onto the study, 2) \>= 75% enrolled participants successfully complete all study measurements (history/physical examination, blood draw, completion of study questionnaires, CT-imaging), 3) \>= 90% of CT-based studies can be interpreted and 4) =\< 100 individuals are approached to achieve recruitment goal of 20 participants.

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States