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Completed

NCT Number: NCT02077218

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

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.

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Key information

Conditions

Cancer Survivor Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computed Tomography

Procedure

Undergo cardiac CT

Other names: tomography, computed

Cytology Specimen Collection Procedure

Other

Undergo collection of blood samples

Other names: cytologic sampling

laboratory biomarker analysis

Other

Correlative studies

Questionnaire Administration

Other

Ancillary studies

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

    Time frame: 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.

Other outcomes

  1. Prevalence of asymptomatic CAD, as measured by CT angiography

    Time frame: Up to 9 weeks

    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.

  2. Severity of asymptomatic CAD, as measured by CT angiography

    Time frame: Up to 9 weeks

    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.

  3. Patient demographics (age, sex, race/ethnicity)

    Time frame: Up to 9 weeks

    Will be evaluated using descriptive statistics.

  4. Pre-HCT chest radiation

    Time frame: Up to 9 weeks

    Will be evaluated using descriptive statistics.

  5. HCT-related exposures (TBI, conditioning chemotherapy)

    Time frame: Up to 9 weeks

    Will be evaluated using descriptive statistics.

  6. Management of GvHD

    Time frame: Up to 9 weeks

    Will be evaluated using descriptive statistics.

  7. CVRF-specific characteristics

    Time frame: Up to 9 weeks

    Will be evaluated using descriptive statistics.

  8. Expression of hs-CRP

    Time frame: Up to 9 weeks

    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.

  9. Expression of Lp-PLA2

    Time frame: Up to 9 weeks

    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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 4, 2014
Registry last updated
Apr 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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