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

NCT02077218 | Completed DMC

• 2 other identifiers: 13385NCI-2014-00419
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Survivor; Diabetes Mellitus; Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Up to 9 weeks

Other Outcomes (9)

• Prevalence of asymptomatic CAD, as measured by CT angiography

  Up to 9 weeks

• Severity of asymptomatic CAD, as measured by CT angiography

  Up to 9 weeks

• Patient demographics (age, sex, race/ethnicity)

  Up to 9 weeks

Study Arms (1)

Diagnostic (CT and blood biomarkers)

EXPERIMENTAL

Patients undergo cardiac CT and collection of blood samples for analysis of hs-CRP via quantitative immunoturbidimetry and Lp-PLA2 via ELISA.

Procedure: computed tomography; Other: cytology specimen collection procedure; Other: laboratory biomarker analysis; Other: questionnaire administration

Interventions

computed tomography PROCEDURE

Undergo cardiac CT

Also known as: tomography, computed

Diagnostic (CT and blood biomarkers)

cytology specimen collection procedure OTHER

Undergo collection of blood samples

Also known as: cytologic sampling

Diagnostic (CT and blood biomarkers)

laboratory biomarker analysis OTHER

Correlative studies

Diagnostic (CT and blood biomarkers)

questionnaire administration OTHER

Ancillary studies

Diagnostic (CT and blood biomarkers)

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Saro Armenian

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2014
• First Posted: March 4, 2014
• Study Start: February 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 21, 2015

Record last verified: 2015-04

Locations

US (1)