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Gregory P. Fontana, M.D.

joins the SCRI team this spring as the


SCRI Medical Director of Cardiovascu-
lar Research. In addition to his role at
SCRI, he serves as:
HCA National Group Medical Direc-
tor of Cardiovascular Research and
Innovation
Medical Director of Cardiovascular
Services and Cardiothoracic
Surgery at Los Robles Hospital and
Medical Center

Dr. Fontana received his medical degree from the David Geffen
School of Medicine at UCLA and has over twenty years of adult/
pediatric cardiac surgery experience. He serves at the National PI
Chair for the St. Jude Medical PORTICO transcatheter aortic valve
IDE trial.

Clinicians often wrestle with the ability to forecast and stratify patients as medication responders versus non-
responders. Predicting treatment outcomes based on the clinical exam and medical history is helpful, but re-
mains limited in its ability to offer prognostic value to the individual patient. Often, medications for heart fail-
ure are prescribed with the notion they will work relatively the same for all patients. The ability to genotype a
patient profile using a blood test prior to the initiation of therapy would reduce the amount of trial-and-error
strategy and telescope individualized care. One example of this strategy is utilized in a clinical trial at both
Medical City Dallas Hospital and Redmond Regional Medical Center. Sponsored by ARCA BioPharma, the GE-
NETIC A-FIB study uses pharmacogenomics to provide a more informed and personalized treatment plan for
patients with heart failure. During the screening phase of the trial, patients complete a blood test to see if the
1389 Arg/Arg genotype is present. If so, consent is obtained, enrolled and randomized to either the study
medication, Bucindolol, or an FDA-approved beta-blocker, Toprol-XL. The primary endpoint of GENETIC-AF is to
demonstrate the superiority of pharmacogenetically targeted bucindolol compared to metoprolol for the pre-
vention of symptomatic atrial fibrillation or atrial flutter in a genotype-defined (1389 Arg/Arg) population with
heart failure. For more study-specific information, please refer to this trial by its ClinicalTrials.gov identifier:
NCT01970501
sarahcannonresearch.com/cv
By Gina Remington, Director of Research, North Texas Division

While sitting at lunch, a colleague expresses concern about her own cardiovascular
health due to a family member recently hospitalized with a stroke. What information
would be helpful to inform and inspire her regarding stroke risk and management?

The 2015 Heart Disease and Stroke Statistics Update stated the risk of cardiovascular
disease is approximately 50% higher in patients with a first-degree relative that has a previous
medical history of stroke (AHA statistical update, 2015). Despite medical advancements in the treatment of both is-
chemic and hemorrhagic stroke, one life is lost every 4 minutes to this horrific event. In addition, approximately one
person every 40 seconds experiences the life-altering events of a cerebrovascular attack, contributing to a leading
cause of adult disability in the United States that often requires a long-term caregiver support network and a team of
healthcare professionals to promote recovery (AHA statistical update, 2015).

But theres more to the story than statistics Think FAST: Spot a stroke by observing Facial drooping, Arm weakness,
and Speech difficulty. Time is Brain: clinical outcomes decline with each passing minute prior to emergency interven-
tion. According to the American Stroke Association (2015), approximately 80% of reported stroke events are preventa-
ble. Community awareness related to the signs and symptoms of stroke as well as improved public health initiatives
have significantly improved clinical outcomes. A decline in the incidence of stroke mortality over the last decade is at-
tributable to enhanced preventative and comprehensive care for patients with co-morbidities that contribute to in-
creased risk of stroke, including diabetes, high cholesterol, hypertension, and history of smoking (AHA Stroke Counsel,
2015).

Currently, the only approved medical therapy for acute ischemic stroke is tissue plasminogen activator (tPA). This agent
targets the blood clot within the affected vessel and needs to be given within several hours from onset of stroke-related
symptoms.

What is on the horizon for recovery after a stroke? Long-term clinical outcomes stem from the ability to halt persistent
damage occurring immediately following a stroke, while promoting an environment ripe for repair. Clinical trials investi-
gating neuroprotective strategies are underway and in search of a safe and tolerable endovascular intervention that
protects neurons in the brain from irreversible injury. The outer layers of affected cerebral tissue, called the penumbra,
also offer an opportunity to investigate immune cells that either contribute to further damage or catalyze repair. Fur-
thermore, neuro-imaging provides a metaphorical window into the brain to allow visualization of the cascading path-
ways induced by a stroke, including recruitment and activation of pro-inflammatory cells, oxidative stress at the site of
injury, and disruption of the gatekeeper of the brain, called the blood-brain barrier. Recently, a forum brought together
neurologists, neuro-radiologists, and neuroimaging scientists to create a roadmap, called the Acute Stroke Imaging Re-
search Roadmap. This effort provides a guide for the standardization of imaging protocols and optimal imaging methods
across the United States in conjunction with the positive results from recent endovascular trials.

Ischemic and hemorrhagic stroke research embrace a similar goal: to identify strategies to promote recovery and repair
for the patient and family grappling with the dramatic shifts in quality of life following a stroke.

Remember to act FAST to enhance identification and treatment of patients experiencing a stroke.

References
1. Executive Summary: Heart Disease and Stroke Statistics2015 Update: A report from the American Heart Associa-
tion. Circulation. 2015. 131:434-441.
2. National Institute of Neurological Disorders, Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for
acute ischemic stroke. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. N
Engl J Med. 1995 Dec 14. 333(24):1581-7.
SPONSOR TRIAL INDICATION SITE (Investigator)
Medtronic AdaptResponse Heart Failure Centennial Medical Center (Dr. Peter Borek)
Coliseum Medical Center (Dr. Maria Bartlett)
AstraZeneca ARTEMIS Antiplatelet Northside Hospital (Dr. Andrew Rosenthal)
affordability after MI Henrico Doctors Hospital (Dr. Minh Bui)
Riverside Community Hospital (Dr. Patrick Hu)
Bristol-Myers AUGUSTUS AFib/ACS Memorial Hospital (Dr. Van Crisco)

St. Jude Medical CardioMEMS HF Heart Failure Centennial Medical Center (Dr. Thomas Johnston)
Medical City Hospital (Dr. Michael Isaac)
St. Jude Medical CLAS Device Implant/ Redmond Regional Medical Center (Dr. Robert Styperek )
Registry
St. Jude Medical ENHANCE CRT Device Registry Northside Hospital (Dr. Robert Sheppard)
Medical City Hospital (Dr. Michael Isaac)
Boston Scientific EVOLVE Short DAPT PCI Riverside Community Hospital (Dr. Syed Bokhari)

Medtronic FAME 3 Coronary Artery Dis- Centennial Medical Center (Dr. Paul Myers & Dr. Seenu Reddy)
ease
ARCA Biopharma GENETIC AF Atrial Fib/Flutter Medical City Dallas Hospital (Dr. Eric Eichorn)
Boehringer Chippenham Hospital (Dr. Denise Dietz)
Ingelheim GLORIA Atrial Fibrillation Coliseum Medical Center (Dr. Maria Bartlett)
Northside Hospital (Dr. Francisco Cardona)
OrthoGrid HipGrid Total Hip Arthroplasty Southern Joint Replacement Institute (Dr. Jefferey Hodrick)
St. Jude Medical LEADLESS II IDE Redmond Regional Medical Center (Dr. Robert Styperek)
Left Ventricular
Oxy Biotherapeutics LEVO-CTS Systolic Redmond Regional Medical Center (Dr. Daniel Goldfaden)
Dysfunction
Milestone Pharma NODE 1 PSVT Northside Hospital (Dr. Francisco Cardona)
Janssen ORBIT Atrial Fibrillation Redmond Regional Medical Center (Dr. Rahul Garg)

Medtronic ONYX Stent IDE Centennial Medical Center (Dr. Paul Myers)
Medtronic PSR Device Registry Centennial Medical Center (Dr. Chris Jones)
Edwards PARTNER II S3 CAP II Aortic Medical City Hospital (Dr. Bruce Bowers & Dr. Todd Dewey)
Stenosis
St. Jude Medical PORTICO Aortic Centennial Medical Center (Dr. Seenu Reedy &
Stenosis Dr. John Riddick)
University of RAID Heart Failure Medical City Hospital (Dr. Michael Isaac)
Rochester
Boston Scientific REPRISE III TAVR Medical City Hospital (Dr. Todd Dewey)
Bard SAFE DCB PAD Memorial Hospital (Dr. Van Crisco)
Centennial Medical Center (Dr. Brian Jefferson)
Medicure SAVI-PCI Aggrastat in PCI Chippenham Hospital (Dr. Michael Arcarese)
Redmond Regional Hospital (Dr. Hector Picon)
Thoratec SHIELD II IDE Memorial Hospital (Dr. Van Crisco)

Sensible Medical SMILE Heart Failure Centennial Medical Center (Dr. Tom McRae)
Henrico Doctors Hospital (Dr. Christopher Nicholson)
Pfizer SPIRE 1&2 Hyperlipidemia Chippenham Hospital (Dr. Michael Arcarese)
Coliseum Medical Center (Dr. Maria Bartlett);
AstraZeneca TWILIGHT PCI Memorial Hospital (Dr. Van Crisco)
Blake Medical Center (Dr. Enrique Rivera)
Medtronic WRAP-IT Device Registry Centennial Medical Center (Dr. Chris Jones)

sarahcannonresearch.com/cv
GENETIC AF A Genotype-Directed Comparative Effectiveness Trial of Bucindolol and Toprol-XL for Prevention of Symptomatic
Atrial Fibrillation/Atrial Flutter in Patients With Heart Failure

HipGrid Validity and Reliability of intraoperative surgeon assessment of component position in Anterior THA using a novel
fluoronavigation technique based on the transteardrop line and a second generation radiopaque grid

PARTNER II S3 CAP II TAVR Implantation of the Transcatheter Aortic Valve Prosthesis

PORTICO Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial

SHEILD II Coronary InterventionS in HIgh-Risk PatiEnts Using a Novel Percutaneous Left Ventricular Support Device

Please welcome Sally Mathews as the new Site Manager to our core
team. Sally previously served as our Blake Medical Center clinical re-
search coordinator. She is a nurse with 33 years of EP experience that
spans clinical and industry experience, clinical research site selection
and qualification/support of clinical studies to support enrollment. She
Sally speaking on the Blake Medicals TV special,
will serve as site manager for the South Atlantic and West Florida divi-
Healthstream
sions.

Sybil Hyatt Dr. Gregory Fontana


Director Of Operations Medical Director
Sybil.Hyatt@scresearch.net Gregory.Fontana@hcahealthcare.com
615.693.9490

Gina Remington Sally Mathews


Director of Research, North Texas Site Manager
Gina.Remington@scresearch.net Blake, Coliseum, Memorial, Northside
352.745.0055 Sally.Mathews@scresearch.net
941.650.9750

Lynn Anton
Adrian Fencl
Site Manager
Research Nurse Educator
Centennial, Chippenham, Henrico,
Adrian.Fencl@scresearch.net Redmond, Riverside
615.524.4163 Lynn.BlairAnton@scresearch.net
615.483.1559
Katie Johnson Abby Winstead
Program Relations Specialist Business Development Coordinator
Katie.Johnson@scresearch.net Abigail.Winstead@scresearch.net
615.524.4049 615.329.7290

sarahcannonresearch.com/cv 615-329-7274 cann.cvresearch@hcahealthcare.com

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