Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The MyLeukoMAPâ„¢ Pivotal Clinical Study will assess the accuracy of MyLeukoMAPâ„¢, 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.
The MyLeukoMAPâ„¢ Pivotal Clinical Study will assess the accuracy of MyLeukoMAPâ„¢, 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 MyLeukoMAPâ„¢ 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Survival / Non-Survival | Patient Survival Status | 1-year (365-455 Days) Post Intervention |
Not provided
Not provided
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)
-
Exclusion Criteria:
Criteria #1: No informed consent Criteria #2: <18 years old
-
Not provided
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simran Prajapat, PhD | Contact | 617.820.3725 | sprajapat@researchdx.com | |
| Gordon Vansant, PhD | Contact | 760.473.4295 | gvansant@researchdx.com |
| Name | Affiliation | Role |
|---|---|---|
| Megan Kamath, MD | University California Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | Recruiting | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29236770 | Result | 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. | |
| 29737882 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
Not provided
Not provided
Not provided
Not provided
Not provided
Peripheral Blood Mononuclear Cells
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 |
|
| AdventHealth Orlando | Recruiting | Orlando | Florida | 32803 | United States |
|
| Saint Luke's Hospital of Kansas City | Recruiting | Kansas City | Missouri | 64111 | United States |
|
| Result |
| 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. |
| 25517110 | Result | 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 response in patients with advanced heart failure. PLoS One. 2014 Dec 17;9(12):e115097. doi: 10.1371/journal.pone.0115097. eCollection 2014. |