MyLeukoMAP™ Genomic Survival Prediction Assay Pivotal Clinical Study
Study Details
Study Description
Brief Summary
The MyLeukoMAP™ Pivotal Clinical Study will assess the accuracy of MyLeukoMAP™, a new molecular blood test, performed within 30 days before scheduled surgical / interventional therapies for Heart Failure, to determine its effectiveness in improving clinical decision support by providing a quantitative prediction of low, indeterminate, or high risk of death one year after surgical / interventional therapies that is not identified by current diagnostic tools.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The MyLeukoMAP™ Pivotal Clinical Study will assess the accuracy of MyLeukoMAP™, a new molecular blood test, performed within 30 days before scheduled surgical / interventional therapies for Heart Failure, to determine its effectiveness in improving clinical decision support by providing a quantitative prediction of low, indeterminate, or high risk of death one year after surgical / interventional therapies that is not identified by current diagnostic tools.
Patients scheduled for one of 10 different Heart Failure surgical / interventional therapies will be identified and consented. Four clinical parameters will be collected for each patient: age, white blood cell count, blood pressure, and respiratory rate. Blood samples will be collected concurrent with a routine preoperative blood draw, and peripheral blood mononuclear cells (PBMC's) will be isolated. The PBMC samples will be shipped to ResearchDx, Irvine, CA, for testing using the MyLeukoMAP™ genomic survival prediction assay. Patient 1-year postoperative survival/non-survival data will be reported for each patient.
The samples will be tested 1-year after the intervention of the last enrolled patient, and the data will be compared to actual patient 1-year survival to determine the survival prediction accuracy of the assay. The investigators anticipate that the assay will better identify those 20% of patients who currently do not achieve 1-year postoperative survival, and who would have better odds of survival by remaining on medical therapy, but who cannot be identified with current tools.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Heart Failure Patients Scheduled for Coronary Artery Bypass Graft (CABG) Surgery Heart Failure Patients Scheduled for Coronary Artery Bypass Graft (CABG) Surgery |
Other: Observational
Blood samples will be collected within 30 days before scheduled surgical / interventional therapy for Heart Failure. The study will not impact patient treatment in any way.
|
| Heart Failure Patients Scheduled for Percutaneous Coronary Interventions (PCI) Heart Failure Patients Scheduled for Percutaneous Coronary Interventions (PCI) |
Other: Observational
Blood samples will be collected within 30 days before scheduled surgical / interventional therapy for Heart Failure. The study will not impact patient treatment in any way.
|
| Heart Failure Patients Scheduled for Aortic Valve Replacement (AVR) Surgery Heart Failure Patients Scheduled for Aortic Valve Replacement (AVR) Surgery |
Other: Observational
Blood samples will be collected within 30 days before scheduled surgical / interventional therapy for Heart Failure. The study will not impact patient treatment in any way.
|
| Heart Failure Patients Scheduled for Mitral Valve Replacement (MVR) Surgery Heart Failure Patients Scheduled for Mitral Valve Replacement (MVR) Surgery |
Other: Observational
Blood samples will be collected within 30 days before scheduled surgical / interventional therapy for Heart Failure. The study will not impact patient treatment in any way.
|
| Heart Failure Patients Scheduled for Transcatheter Aortic Valve Replacement (TAVR) Heart Failure Patients Scheduled for Transcatheter Aortic Valve Replacement (TAVR) |
Other: Observational
Blood samples will be collected within 30 days before scheduled surgical / interventional therapy for Heart Failure. The study will not impact patient treatment in any way.
|
| Heart Failure Patients Scheduled for Transcatheter Mitra Clip Heart Failure Patients Scheduled for Transcatheter Mitra Clip |
Other: Observational
Blood samples will be collected within 30 days before scheduled surgical / interventional therapy for Heart Failure. The study will not impact patient treatment in any way.
|
| Heart Failure Patients Scheduled for Ventricular Tachycardia Ablation Heart Failure Patients Scheduled for Ventricular Tachycardia Ablation |
Other: Observational
Blood samples will be collected within 30 days before scheduled surgical / interventional therapy for Heart Failure. The study will not impact patient treatment in any way.
|
| Heart Failure Patients Scheduled for Stellate Gangliectomy Heart Failure Patients Scheduled for Stellate Gangliectomy |
Other: Observational
Blood samples will be collected within 30 days before scheduled surgical / interventional therapy for Heart Failure. The study will not impact patient treatment in any way.
|
| Heart Failure Patients Scheduled for Mechanical Circulatory Support (MCS) Surgery Heart Failure Patients Scheduled for Mechanical Circulatory Support (MCS) Surgery |
Other: Observational
Blood samples will be collected within 30 days before scheduled surgical / interventional therapy for Heart Failure. The study will not impact patient treatment in any way.
|
| Heart Failure Patients Scheduled for Heart Transplantation (HTx) Surgery Heart Failure Patients Scheduled for Heart Transplantation (HTx) Surgery |
Other: Observational
Blood samples will be collected within 30 days before scheduled surgical / interventional therapy for Heart Failure. The study will not impact patient treatment in any way.
|
Outcome Measures
Primary Outcome Measures
- Survival / Non-Survival [1-year (365-455 Days) Post Intervention]
Patient Survival Status
Eligibility Criteria
Criteria
Inclusion Criteria:
Criteria #1: AdHF with NYHA III/IV
Criteria #2: Left Ventricular Ejection Fraction (LVEF) <35% or >2+valvular disease severity & >low risk Society of Thoracic Surgeons (STS)-score
Criteria #3: Evaluation for interventions including CABG/PCI (Stratum #1, Ischemia), Surgical Valve Replacement/TAVR/Mitra-Clip (Stratum #2, Overload), VT-Ablation/Stellate Gangliectomy (Stratum #3, Arrhythmia), or MCS/HTx (Stratum #4, Contractility)
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Exclusion Criteria:
Criteria #1: No informed consent Criteria #2: <18 years old
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Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Saint Luke's Hospital of Kansas City | Kansas City | Missouri | United States | 64111 |
Sponsors and Collaborators
- LeukoLifeDx Inc
Investigators
- Principal Investigator: Megan Kamath, MD, University California Los Angeles
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LLDx1012021