MyLeukoMAP™ Genomic Survival Prediction Assay Pivotal Clinical Study
1 other identifier
observational
300
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2022
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2022
CompletedFirst Posted
Study publicly available on registry
February 28, 2022
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedOctober 27, 2022
July 1, 2022
11 months
February 17, 2022
October 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Survival / Non-Survival
Patient Survival Status
1-year (365-455 Days) Post Intervention
Study Arms (10)
Heart Failure Patients Scheduled for Coronary Artery Bypass Graft (CABG) Surgery
Heart Failure Patients Scheduled for Coronary Artery Bypass Graft (CABG) Surgery
Heart Failure Patients Scheduled for Percutaneous Coronary Interventions (PCI)
Heart Failure Patients Scheduled for Percutaneous Coronary Interventions (PCI)
Heart Failure Patients Scheduled for Aortic Valve Replacement (AVR) Surgery
Heart Failure Patients Scheduled for Aortic Valve Replacement (AVR) Surgery
Heart Failure Patients Scheduled for Mitral Valve Replacement (MVR) Surgery
Heart Failure Patients Scheduled for Mitral Valve Replacement (MVR) Surgery
Heart Failure Patients Scheduled for Transcatheter Aortic Valve Replacement (TAVR)
Heart Failure Patients Scheduled for Transcatheter Aortic Valve Replacement (TAVR)
Heart Failure Patients Scheduled for Transcatheter Mitra Clip
Heart Failure Patients Scheduled for Transcatheter Mitra Clip
Heart Failure Patients Scheduled for Ventricular Tachycardia Ablation
Heart Failure Patients Scheduled for Ventricular Tachycardia Ablation
Heart Failure Patients Scheduled for Stellate Gangliectomy
Heart Failure Patients Scheduled for Stellate Gangliectomy
Heart Failure Patients Scheduled for Mechanical Circulatory Support (MCS) Surgery
Heart Failure Patients Scheduled for Mechanical Circulatory Support (MCS) Surgery
Heart Failure Patients Scheduled for Heart Transplantation (HTx) Surgery
Heart Failure Patients Scheduled for Heart Transplantation (HTx) Surgery
Interventions
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.
Eligibility Criteria
Study Participants: All study participants will be referred to the AdHF Program at one of the study investigational sites, evaluated for the various therapeutic options outlined below, and scheduled for HF-surgical / interventional therapy. All patients will be optimized regarding HF therapy, consented, and prescribed one of 10 HF procedures according to established guidelines, based on the recommendations of the AdHF team of the participating study centers.
You may qualify if:
- 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)
You may not qualify if:
- Criteria #1: No informed consent Criteria #2: \<18 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LeukoLifeDx Inclead
Study Sites (3)
Yale University
New Haven, Connecticut, 06511, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Related Publications (3)
Bondar G, Togashi R, Cadeiras M, Schaenman J, Cheng RK, Masukawa L, Hai J, Bao TM, Chu D, Chang E, Bakir M, Kupiec-Weglinski S, Groysberg V, Grogan T, Meltzer J, Kwon M, Rossetti M, Elashoff D, Reed E, Ping PP, Deng MC. Association between preoperative peripheral blood mononuclear cell gene expression profiles, early postoperative organ function recovery potential and long-term survival in advanced heart failure patients undergoing mechanical circulatory support. PLoS One. 2017 Dec 13;12(12):e0189420. doi: 10.1371/journal.pone.0189420. eCollection 2017.
PMID: 29236770RESULTDeng MC. A peripheral blood transcriptome biomarker test to diagnose functional recovery potential in advanced heart failure. Biomark Med. 2018 Jun;12(6):619-635. doi: 10.2217/bmm-2018-0097. Epub 2018 May 8.
PMID: 29737882RESULTBondar G, Cadeiras M, Wisniewski N, Maque J, Chittoor J, Chang E, Bakir M, Starling C, Shahzad K, Ping P, Reed E, Deng M. Comparison of whole blood and peripheral blood mononuclear cell gene expression for evaluation of the perioperative inflammatory response in patients with advanced heart failure. PLoS One. 2014 Dec 17;9(12):e115097. doi: 10.1371/journal.pone.0115097. eCollection 2014.
PMID: 25517110RESULT
Biospecimen
Peripheral Blood Mononuclear Cells
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Megan Kamath, MD
University California Los Angeles
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2022
First Posted
February 28, 2022
Study Start
July 1, 2022
Primary Completion
June 1, 2023
Study Completion
August 1, 2023
Last Updated
October 27, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share