MyLeukoMAP™ Genomic Survival Prediction Assay Pivotal Clinical Study

Heart Failure Clinical Trial

Official title:

MyLeukoMAP™ Genomic Survival Prediction Assay for Heart Failure Pivotal Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05258942
• Other study ID #: LLDx1012021
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: August 2023

Study information

• Verified date: July 2022
• Source: LeukoLifeDx Inc
• Contact: Simran Prajapat, PhD
• Phone: 617.820.3725
• Email: sprajapat[@]researchdx.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 2023
• Est. primary completion date: June 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	Yale University	New Haven	Connecticut
United States	AdventHealth Orlando	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
LeukoLifeDx Inc

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bondar 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 resp — View Citation

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 pe — View Citation

Deng 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival / Non-Survival	Patient Survival Status	1-year (365-455 Days) Post Intervention