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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02077218
• Other study ID #: 13385
• Secondary ID: NCI-2014-0041913
• Status: Completed
• Phase: N/A
• First received: February 28, 2014
• Last updated: April 17, 2015
• Start date: February 2014
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cancer Survivor
• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Hypertension
• Myocardial Ischemia

Intervention

Procedure:
• computed tomography
Undergo cardiac CT

Other:
• cytology specimen collection procedure
Undergo collection of blood samples
• laboratory biomarker analysis
Correlative studies
• questionnaire administration
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prevalence of asymptomatic CAD, as measured by CT angiography	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.	Up to 9 weeks	No
Other	Severity of asymptomatic CAD, as measured by CT angiography	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.	Up to 9 weeks	No
Other	Patient demographics (age, sex, race/ethnicity)	Will be evaluated using descriptive statistics.	Up to 9 weeks	No
Other	Pre-HCT chest radiation	Will be evaluated using descriptive statistics.	Up to 9 weeks	No
Other	HCT-related exposures (TBI, conditioning chemotherapy)	Will be evaluated using descriptive statistics.	Up to 9 weeks	No
Other	Management of GvHD	Will be evaluated using descriptive statistics.	Up to 9 weeks	No
Other	CVRF-specific characteristics	Will be evaluated using descriptive statistics.	Up to 9 weeks	No
Other	Expression of hs-CRP	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.	Up to 9 weeks	No
Other	Expression of Lp-PLA2	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.	Up to 9 weeks	No
Primary	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	No