Computed Tomography and Biomarker Analysis in Diagnosing Coronary Artery Disease in Asymptomatic Patients Who Have Undergone Stem Cell Transplant
NCT ID: NCT02077218
Last Updated: 2015-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
20 participants
INTERVENTIONAL
2014-02-28
2015-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Stem Cell Implantation in Patients Undergoing CABG
NCT01721902
The Long-term and Short-term Efficacy and Safety of Transplantation Autologous Bone Marrow Cells (BMCs) in Patients With the First STEMI (ST Segment Elevation Myocardial Infarction)
NCT01748383
Stem Cell Therapy to Improve Myocardial Function in Patients Undergoing Coronary Artery Bypass Grafting (CABG)
NCT00395811
Assessing the Safety and Effectiveness of Intracoronary Stem Cells in Patients With Refractory Angina
NCT05711849
Cell Therapy in Myocardial Infarction
NCT00350766
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Diagnostic (CT and blood biomarkers)
Patients undergo cardiac CT and collection of blood samples for analysis of hs-CRP via quantitative immunoturbidimetry and Lp-PLA2 via ELISA.
computed tomography
Undergo cardiac CT
cytology specimen collection procedure
Undergo collection of blood samples
laboratory biomarker analysis
Correlative studies
questionnaire administration
Ancillary studies
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
computed tomography
Undergo cardiac CT
cytology specimen collection procedure
Undergo collection of blood samples
laboratory biomarker analysis
Correlative studies
questionnaire administration
Ancillary studies
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
45 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Saro Armenian
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
City of Hope Medical Center
Duarte, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2014-00419
Identifier Type: REGISTRY
Identifier Source: secondary_id
13385
Identifier Type: OTHER
Identifier Source: secondary_id
13385
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.