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

Primary Purpose

Cancer Survivor, Diabetes Mellitus, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
computed tomography
cytology specimen collection procedure
laboratory biomarker analysis
questionnaire administration
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cancer Survivor

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • City of Hope Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (CT and blood biomarkers)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 28, 2014
Last Updated
April 17, 2015
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02077218
Brief Title
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

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Survivor, Diabetes Mellitus, Hypertension

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (CT and blood biomarkers)
Arm Type
Experimental
Arm Description
Patients undergo cardiac CT and collection of blood samples for analysis of hs-CRP via quantitative immunoturbidimetry and Lp-PLA2 via ELISA.
Intervention Type
Procedure
Intervention Name(s)
computed tomography
Other Intervention Name(s)
tomography, computed
Intervention Description
Undergo cardiac CT
Intervention Type
Other
Intervention Name(s)
cytology specimen collection procedure
Other Intervention Name(s)
cytologic sampling
Intervention Description
Undergo collection of blood samples
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Up to 9 weeks
Other Pre-specified Outcome Measures:
Title
Prevalence of asymptomatic CAD, as measured by CT angiography
Description
Asymptomatic CAD will be defined as having either an abnormal coronary artery calcium (CAC) (>= 100 Au) or more than minimal coronary luminal stenosis (>= 30%) in any of the arteries. Descriptive statistics will be generated to characterize the extent of luminal stenosis in the study populations.
Time Frame
Up to 9 weeks
Title
Severity of asymptomatic CAD, as measured by CT angiography
Description
Asymptomatic CAD will be defined as having either an abnormal coronary artery calcium (CAC) (>= 100 Au) or more than minimal coronary luminal stenosis (>= 30%) in any of the arteries. Descriptive statistics will be generated to characterize the extent of luminal stenosis in the study populations.
Time Frame
Up to 9 weeks
Title
Patient demographics (age, sex, race/ethnicity)
Description
Will be evaluated using descriptive statistics.
Time Frame
Up to 9 weeks
Title
Pre-HCT chest radiation
Description
Will be evaluated using descriptive statistics.
Time Frame
Up to 9 weeks
Title
HCT-related exposures (TBI, conditioning chemotherapy)
Description
Will be evaluated using descriptive statistics.
Time Frame
Up to 9 weeks
Title
Management of GvHD
Description
Will be evaluated using descriptive statistics.
Time Frame
Up to 9 weeks
Title
CVRF-specific characteristics
Description
Will be evaluated using descriptive statistics.
Time Frame
Up to 9 weeks
Title
Expression of hs-CRP
Description
Standard descriptive statistics will be utilized to derive the median, mean, standard deviation, and range of individual blood biomarkers in survivors with and without CAD.
Time Frame
Up to 9 weeks
Title
Expression of Lp-PLA2
Description
Standard descriptive statistics will be utilized to derive the median, mean, standard deviation, and range of individual blood biomarkers in survivors with and without CAD.
Time Frame
Up to 9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saro Armenian
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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