Ignite Creation Date:
2024-05-06 @ 2:34 AM
Last Modification Date:
2024-10-26 @ 11:20 AM
Study NCT ID:
NCT02077218
Status:
COMPLETED
Last Update Posted:
2015-04-21
First Post:
2014-02-28
Brief Title:
Computed Tomography and Biomarker Analysis in Diagnosing Coronary Artery Disease in Asymptomatic Patients Who Have Undergone Stem Cell Transplant
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
Assessment of Coronary Artery Disease in Asymptomatic Survivors of Allogeneic Hematopoietic Cell Transplantation HCT A Pilot Feasibility Study
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 raceethnicity 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
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 raceethnicity 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 13385 | OTHER | City of Hope Medical Center | None |
| NCI-2014-00419 | REGISTRY | None | None |