Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2025-12-16 @ 11:09 PM
Study NCT ID:
NCT04656080
Status:
None
Last Update Posted:
2023-01-26 00:00:00
First Post:
2020-10-06 00:00:00
Brief Title:
Cardiopulmonary Stress Testing (CPET) AlloSure Study
Sponsor:
Baylor Research Institute
Organization:
Baylor Research Institute
Study Overview
Official Title:
AlloSure Test Characteristics in Immunologically Quiescent and Immunologically Active Heart Transplant Recipients: Does Maximal Cardiopulmonary Stress Testing Prior to Assay Preserve Test Specificity While Enhancing Sensitivity?
Status:
None
Status Verified Date:
2023-01
Last Known Status:
RECRUITING
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:
The specific research questioned aimed to be addressed with this proposed study are:
i. Are dd-cfDNA levels in heart transplant recipients independent of recent cardiopulmonary exercise? More specifically, does the metabolic demand of maximal cardiopulmonary exercise in recent heart transplant recipients trigger a release of dd-cfDNA (if so, then what is the time course for resolution back to baseline?) ii. If dd-cfDNA does not release to any significant degree with cardiac allografts with short donor-ischemic time, does this test characteristic continue to hold for cardiac allografts transplanted after longer donor ischemic times? iii. In cardiac transplant recipients with medically stabilized, treated antibody-mediated rejection (AMR) and persistent dd-cfDNA elevation, does a discrete episode of maximal cardiometabolic activity trigger any additional elevation of dd-cfDNA, and again, with what time course?
i. Are dd-cfDNA levels in heart transplant recipients independent of recent cardiopulmonary exercise? More specifically, does the metabolic demand of maximal cardiopulmonary exercise in recent heart transplant recipients trigger a release of dd-cfDNA (if so, then what is the time course for resolution back to baseline?) ii. If dd-cfDNA does not release to any significant degree with cardiac allografts with short donor-ischemic time, does this test characteristic continue to hold for cardiac allografts transplanted after longer donor ischemic times? iii. In cardiac transplant recipients with medically stabilized, treated antibody-mediated rejection (AMR) and persistent dd-cfDNA elevation, does a discrete episode of maximal cardiometabolic activity trigger any additional elevation of dd-cfDNA, and again, with what time course?
Detailed Description:
The specific research questioned aimed to be addressed with this proposed study are
i Are dd-cfDNA levels in heart transplant recipients independent of recent cardiopulmonary exercise More specifically does the metabolic demand of maximal cardiopulmonary exercise in recent heart transplant recipients trigger a release of dd-cfDNA if so then what is the time course for resolution back to baseline ii If dd-cfDNA does not release to any significant degree with cardiac allografts with short donor-ischemic time does this test characteristic continue to hold for cardiac allografts transplanted after longer donor ischemic times iii In cardiac transplant recipients with medically stabilized treated antibody-mediated rejection AMR and persistent dd-cfDNA elevation does a discrete episode of maximal cardiometabolic activity trigger any additional elevation of dd-cfDNA and again with what time course
i Are dd-cfDNA levels in heart transplant recipients independent of recent cardiopulmonary exercise More specifically does the metabolic demand of maximal cardiopulmonary exercise in recent heart transplant recipients trigger a release of dd-cfDNA if so then what is the time course for resolution back to baseline ii If dd-cfDNA does not release to any significant degree with cardiac allografts with short donor-ischemic time does this test characteristic continue to hold for cardiac allografts transplanted after longer donor ischemic times iii In cardiac transplant recipients with medically stabilized treated antibody-mediated rejection AMR and persistent dd-cfDNA elevation does a discrete episode of maximal cardiometabolic activity trigger any additional elevation of dd-cfDNA and again with what time course
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None