Las Vegas, Nevada 89052
702-492-1450 http://www.steljescardiology.com/ asteljes@steljescardiology.com
Steljes Clinical Research is a full-time dedicated unit, which is fully integrated within a busy single specialty cardiology practice. The team is passionate about maintaining a thriving program within a competitive environment. We are proud of our past and we keep an eye on the future.
We have excelled in a competitive environment by adhering to several well proven principles.
First, we are selective in choosing protocols. We restrict protocols to those which fit our interest/expertise. We commit to recruitment goals which are realistic relative to our patient population. We do not accept competing protocols.
Secondly, we respect sponsors needs for rapid trial initiation and recruitment. Our internal protocol review, budget negotiation and contracting processes are streamlined. We utilize a central IRB. Once the team accepts a new protocol, we fully commit all our resources to successful implementation.
Third, we recruit only from our own stable patient population. The patients are thoroughly prescreened. We select only patients with proven compliance and commitment.
As a result, we typically meet or exceed recruitment goals. Screen failures are relatively infrequent. We have been successful in maintaining patient compliance in long term studies. We rarely require advertising to meet our goals.
We are particularly pleased that most of our patients "graduating" from a given trial are interested in participating in another trial.
Steljes Cardiology Clinical Research is built upon a solid foundation of Cardiac Medical expertise combined with 20 years of experience conducting Clinical Trials. We have a wealth of Clinical Research experience successfully completing more than 30 Phase II-IV Pharmaceutical Trials.
Our Therapeutic Specialties for Clinical Trials include:
- Angina
- Atrial Fibrillations and other Cardiac Arrythmias
- Cardiac Imaging/Contrast Agents
- Cardiac Pacemaker/Device
- Cardiomyopathy
- Heart Failure
- Hemostasis/Thrombosis
- Hyperlipidemia
- Hypertension
- Perpheral Vascular Disease
- Pharmacoeconomics
- Stable Angina
- Valvular Heart Disease
Alan Steljes, M.D. F.A.C.C., F.R.C.P.C. participated in the following over the past 5 years:
- AstraZeneca Statin 4522IL/0034 (Astra Zeneca)
- AstraZeneca Statin ZD4522IL/0034 - Hypertriglyceridemia (Astra Zeneca)
- AstraZeneca Exanta (INN ximelagatran, H376/95) - Sportif V (Astra Zeneca)
- Valsartan Antihypertensive Long-Term Use Evaluation (VALUE) Trial (Novartis)
- ATHENA- A Placebo-controlled, Double-Blinded, Parallel Arm Trial to Assess the efficacy of Dronedarone 400mg bid for the Prevention of Cardiovascular Hospitalization or Death from Any Cause in Patients with Atrial Fibrillation/Atrial Flutter (AF/AFL) (Sanofi-Aventis)
- DESTINY- A 12-Week Multicenter, Randomized, Double-Blind, 2-Arm Parallel Treatment Regimen, Exploratory Study to Evaluate the Tolerability and Safety of Valsartan Administered Once Daily Versus Twice Daily, in Patients with Stable, Chronic Heart Failure (NYHA Class II-III) (Novartis)
- EVALUATE- A 10-week multicenter, randomized, double-blind, parallel-group, forced-titration study using 24-hr ABPM to evaluate the efficacy of a Valsartan/Hydrochlorothiazide (HCTZ) treatment regimen versus conventional treatment regimen with Amlodipine and hydrochlorothiazide (HCTZ) in patients with Stage 2 Hypertension (Novartis)
- VALVET- A 16 week multi-center, randomized, double-blind study to evaluate efficacy and safety of valsartan.hydrochlorothiazide (HCTZ) combination therapy compared to patients initiated with valsartan monotherapy or hydrochlorothiazide monotherapy in very elderly patients with essential hypertension (Novartis)
- FIRST- Evaluation of Choline Fenofibrate (ABT-335) on Carotid Intima-Media Thickness (cIMT) in Subjects with Type IIb Dyslipidemia with Residual Risk in Addition to Atorvastatin Therapy (FIRST) Trial (Abbott)
- RELY- Randomized Evaluation of Long term anticoagulant therapy (RE-LY) comparing the efficacy and safety of two blinded doses of Dabigatran etexilate with open label Warfarin for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation: prospective, multi-centre, parallel-group, non-inferiority trial (RE-LY STUDY) (Boehringer Ingelheim)
- RELY-ABLE- Long term multi-center extension of Dabigatran treatment in patients with atrial fibrillation who completed the RE-LY trial and a cluster randomized trial to assess the effect of a knowledge translation intervention on patient outcomes (Boehringer Ingelheim)
- ENGAGE-AF- A Phase 3, Randomized, Double-Blinded, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of DU-176B Versus Warfarin in Subjects with Atrial Fibrillation-Effective anticoagulation with factor xA next Generation in Atrial Fibrillation (ENGAGE AF - TIMI 48) (Daiichi Sankyo)
- EMBRACE- A Randomized, Double-Blind Comparison of ATI-5923, a Novel Vitamin K Antagonist with Warfarin in Patients Requiring Chronic Anticoagulation (Aryx)
- SAVOR- Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus- A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients with Type 2 Diabetes
The Clinical Team consists of a principal investigator, a sub-investigators (Blanca Tenhet, PA-C) and a full time in-house coordinator (Elizabeth Ortiz). Part time coordinators are available on a contract basis as needed.
The Clinical Team is trained in Good Clinical Practices, and meets on a regular basis for research and trial updates.
Our practice is comprised of more than 5000 patients covering the full spectrum of Cardiac Disease.
Our office draws from a diverse pool of potential patients. The Las Vegas area has a population of nearly 2 million people.
| Gender | Male | Female | |||
| 49.5% | 50.5% | ||||
| Race | White | African American | Asian | Latino | Other |
| 81% | 4.2% | 5.9% | 3.6% | 5.3% | |
| Age | 25-34 | 35-44 | 45-54 | 55-64 | 65+ |
| 16% | 16% | 18% | 21% | 29% |
Cardiology/Vascular Diseases
The research unit is housed within a cardiology practice. We are located in Henderson, Nevada, an affluent but ethnically diverse suburb of Las Vegas. We just moved to a brand new state of art facility where 500 square feet has been dedicated to clinical research. This includes a dedicated area to comfortably accommodate monitors during each visit. Also included are dedicated examination rooms, an area for blood draws, processing and storage, secure and environmentally controlled drug storage area, and facilities for active chart storage and for long term archiving.
The unit is physically and electronically integrated within the cardiology practice.
The physician practice is a well-established, single specialty referral practice dedicated to quality and comprehensive patient care. The physician is board certified in internal medicine, cardiovascular diseases, nuclear cardiology and echocardiography. The in-house diagnostic services are nationally credited.
We have ready access to TEE, cardiac CT and MRI nearby.
The patient records are archived electronically. The EMR system confirms to all national standards. Proprietary "data-mining" software can quickly assemble lists of potential research subjects.
Alan Steljes, MD
Principal Investigator
Steljes Cardiology Research Center
2839 St. Rose Parkway, Suite 160
Henderson, NV 89052
USA
702-492-1450
702-492-1978 (fax)
asteljes@steljescardiology.com
www.steljescardiology.com/