Ascension St. John Clinical Research

St. John Clinical Research coordinates and conducts clinical trials by equipping investigators with an efficient infrastructure, a committed research staff and operational expertise. With research support in varying capacities, the department helps determine the safety and effectiveness of devices, diagnostic products, medications and treatment regimens intended for patient use. It also supports the research mission of Ascension St. John by facilitating research funding, managing funded projects and educating research personnel on current state, federal and funding agency-specific research policies and procedures. Investigators are physicians trained and credentialed for clinical trials in their respective fields.

Full-time registered nurse research coordinators dedicate 100 percent of their time to trials, and clinical staff are specially trained to perform research procedures and collect data as mandated by study protocol and federal, state and local regulations and guidelines. Regulatory oversight and ethics submissions are managed by a regulatory specialist dedicated to clinical research compliance.

All research staff receive training in human subject protections through the Collaborative Institutional Training Initiative (CITI) Program every three years and the National Institutes of Health annually. Physicians and other staff comprise the roster of Ascension St. John’s Institutional Review Board (IRB), a committee that performs ethical reviews of proposed research. The IRB is registered with the U.S. Department of Health & Human Services, which grants Ascension St. John a Federal wide Assurance and, therefore, federal support for research involving human subjects trials. If you are interested in participating in a clinical trial, please contact the Ascension St. John Clinical Research Institute at 918-744-3426 or clinicalresearch@sjmc.org.

The Clinical Research Institute coordinates and conducts a variety of clinical trials, including ones for the following therapeutic areas:

• Cardiovascular diseases
• Dermatology
• Devices
• Endocrinology
• Gastroenterology
• Genetic diseases
• Healthy volunteers
• Hepatology (liver, pancreas and gall bladder)
• Infections and infectious diseases
• Internal medicine
• Nephrology
• Neurology
• Nutrition and weight loss
• Orthopedics and orthopedic surgery
• Pulmonary and respiratory diseases
• Sleep
• Trauma (emergency, injury and surgery)
• Vaccines In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators.

These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as diet. Trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients or to no intervention. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful or no different than available alternatives (including no intervention). The investigators try to determine the safety and effectiveness of the intervention by measuring certain outcomes in the participants.

Active Trials

The following clinical trials by St. John Health System are open for patient enrollment. For a list of all active trials, click here.

St. John Heart and Vascular Center:

• ECLIPSE – A study to evaluate the treatment strategies for severe coronary artery calcification: orbital atherectomy vs. conventional angioplasty technique prior to implantation of drug-eluting stents. The divide is the Diamondback 360® Coronary Orbital Atherectomy System (OAS) 1.25 mm classic crown.
• GEMINI – A drug study to compare the safety of rivaroxaban with acetylsalicylic acid, in addition to either clopidogrel or ticagrelor therapy for acute coronary syndrome.
• GRAFTMASTER – A device study to assess a coronary stent graft system for the treatment of free perforations defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts more than 2.75 mm in diameter.
• LOW-RISK TAVR – A device study to measure the feasibilty of transcatheter aortic valve replacement in low-risk patients with symptomatic, severe aortic stenosis. This study is currently allowing only enrollment in the bicuspid arm.
• PIONEER HF – A drug study to assess the effect of in-hospital initiation of sacubitril/valsartan compared with enalapril.
• TAVR – A device study to measure the quality of care for patients receiving transcatheter valve therapy. St. John Neurosurgery
• CORDIS ENTERPRISE HUD – A device study to assess a vascular reconstruction system.
• DYSTONIA HUD – A device study required by the U.S. Food & Drug Administration to allow patients to undergo deep brain stimulation surgery for the treatment of dystonia.
• LVIS HUD – A device study to evaluate the safety and benefits of the low-profile visualized intraluminal support (LVIS and LVIS Jr.) devices from MicroVention Inc. when used to facilitate endovascular coiling of unruptured, wide-necked, intracranial aneurysms with bare platinum embolization coils.
• WINGSPAN HUD – A device study to assess the Wingspan Stent System with Gateway PTA Balloon Catheter. St. John Neurology/Stroke Center
• ARAMIS – A study to address real-world anticoagulant management issues in stroke registry.
• CREST 2 – A study on carotid revascularization and medical management for asymptomatic carotid stenosis.
• MaRISS – A study to evaluate treatment options for patients with mild and rapidly improving stroke symptoms.

St. John Trauma Center

• ARDS – A Phase I study comparing outcomes in trauma-specific refractory acute respiratory distress syndrome (ARDS) using a high-frequency oscillatory ventilator versus “proning” as a salvage protocol.
• RE-VERSal – A Phase III, case series study of the reversal of the anticoagulant effects of dabigatran by intravenous administration of 5g idarucizumab (BI 655075) in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.

St. John Breast Center

• MAMMOGRAM CAD* – An observational study to improve the detection of breast cancer using a novel computer-assisted diagnosis system and analytic approach applied to mammography. *These clinical trials are conducted in collaboration with the national Ascension Clinical Research Institute, which brings together research sites at Ascension ministries across the country to share resources and expertise. Participation Research needs both researchers and volunteers. Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of clinical research that helps produce reliable results. Participation criteria may include age, gender, type and stage of disease, treatment history, and other medical conditions. A participant must qualify for the study before being consented for a clinical trial. The ethical and legal codes that govern medical practice also apply to clinical trials. A participant should evaluate the potential risks and benefits before participating. The details of your care during a study will be reviewed during a consultation with an RN research coordinator.

During a consultation, the following information is reviewed with the candidate:

• Why researchers believe the experimental treatment may be effective
• Whether the experimental treatment has been previously tested
• Kinds of tests involved, if any
• Possible risks, side effects and benefits and how they compare with current treatment
• Participant’s responsibilities and how long the study will last
• Follow-up care after study
• Evaluation methods for experimental treatment

Candidates should ask questions, like:

• What can I expect if I participate?
• What are the possible risks?
• Will the research help me personally?
• Can I leave the study at any time?
• Will it cost me anything?

Participants' care is often covered by insurance, including Medicare and Medicaid. Please check with your provider. If you're interested in participating in a clinical trial, please contact the St. John Clinical Research Institute at 918-744-3426 or clinicalresearch@sjmc.org.

Sponsor/Industry Resources

The St. John Clinical Research Institute provides research support to several "centers of excellence" within St. John Health System. Departments that often use Clinical Research Institute resources include:

• St. John Center for Women’s Health
• St. John Heart and Vascular Center
• St. John NeurosurgerySt. John Neurology/Stroke

St. John Trauma Center Scope of services include:

• Phase IIb-IV drug trials
• Clinical safety and efficacy
• Dose ranging and definition
• Efficacy and safety in special populations
• Labeling and claims support
• Post-marketing surveillance Device trials
• Classes I-III
• Premarket approval
• Investigational device exemption
• Humanitarian device exemption Ancillary services
• Protocol preparation
• Study design
• Source document form design
• IRB preparation and submission
• Budget analysis and negotiation
• Contract review
• -80° freezer

Investigational drug/device storage, a double locked entry system and a laboratory for processing research specimens with freezer and refrigerator storage are located on site at the Clinical Research Institute.