Clinical Trials

Beaumont Health System, with three hospitals in the northern Detroit suburbs serving southern Michigan and beyond, is a highly productive contributor to clinical trials across the nation. The Beaumont Research Institute, established by the hospital’s Board of Trustees in 1966, strengthens Beaumont's ability to conduct medical research and to provide a research training experience for the medical staff and participants in graduate medical education programs.

A COMPARISON OF INTRAOCULAR PRESSURES DURING PROLONGED TRENDELENBURG POSITIONING IN MORBIDLY OBESE AND THIN PATIENTS: A PILOT STUDY

Status: open and enrolling

Approval Date: 12/5/2011

The major determinants of intraocular pressure (IOP) are aqueous humor production, aqueous humor outflow, choroidal blood volume, and episcleral venous pressure.  Acute and chronic increased IOP have been demonstrated to be associated with excavation of optic nerve tissue, leading to visual field defects.

Postoperative visual loss is a rare but devastating complication.  The exact causes of postoperative visual loss are still unclear, but intraoperative hypotension, anemia, and positioning have all been implicated as potential risk factors.

When placed in the Trendelenburg position, venous drainage from the head is impaired and presumably a resultant increase in central venous pressure impacts IOP. 

Obesity and increased body mass index (BMI) are associated with a number of physiologic changes, many of which are accentuated in the supine position and during general anesthesia.  Lung functional residual capacity decreases, atelectasis increases, and hypoxemia results.  Mechanical ventilation is more difficult due to increased abdominal mass, and this is accentuated with pneumoperitoneum and body position changes, especially when in steep Trendelenburg position.  Pneumoperitoneum plus Trendelenburg position in the obese results in increased airway pressures (required to inflate the lungs and provide for adequate oxygenation), and progressive difficulty with CO2 elimination. 

It is unclear if obesity itself is a risk factor for increased IOP, but obese patients in prolonged Trendelenburg position with pneumoperitoneum would seem to be at the highest risk of IOP rise.  We have designed this study to measure rate of rise of IOP and highest achieved IOP in cases of long duration.  We also wish to determine if obese patients have a higher peak IOP increase compared to thin controls.


A post marketing observational study to assess respiratory tract adverse events in pulmonary arterial hypertension patients treated with Tyvaso inhalation solution

Status: open and enrolling

Approval Date: 10/19/2011

Tyvaso is an inhaled drug recently approved in the United States for treatment of pulmonary arterial hypertension (PAH).  Researchers want to better understand the long-term safety of this drug compared to other therapies for PAH.  Information about your current drug treatment as normally prescribed by your doctor and certain reactions to the drug treatments will be recorded into the registry.  The objective of this study is to describe the type and frequency of pulmonary adverse events that may be associated with certain treatments for PAH.


Pulmonary Arterial Hypertension (PAH) Quality Enhancement Research Initiative Extension Program

Status: open and enrolling

Approval Date: 10/13/2011

To improve the management of PAH patients through evidence-based approach aimed at achieving optimal WHO functional class.  This study is seeking patients with a specific condition, pulmonary arterial hypertension.


A CLINICAL OUTCOMES STUDY TO COMPARE THE EFFECT OF FLUTICASONE FUROATE/VILANTEROL INHALATION POWDER 100/25MCG WITH PLACEBO ON SURVIVAL IN SUBJECTS WITH MODERATE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) AND A HISTORY OF OR AT INCREASED RISK FOR CARDIOV

Protocol HZC113782 A Phase III, randomized, double-blind, parallel-group, multi-center study evaluating FF/VI 100/25mcg, each component individually, and placebo on Survival in Subjects with moderate Chronic Obstructive Pulmonary Disease and a history of or increased risk for cardiovascular disease.

Status: closed

Approval Date: 10/10/2011

Despite a potential link between the pathogenetic mechanisms involved in Chronic Obstructive Pulmonary Disease (COPD) and atherosclerotic cardiovascular disease, there are no currently approved therapies for patients with COPD that have clearly shown an additional beneficial effect in patients with cardiovascular comorbidities. The TOwards a Revolution in COPD Health (TORCH) study assessed the impact of the inhaled corticosteroid (ICS) fluticasone propionate (FP) in combination with the long-acting beta agonist (LABA), salmeterol (SAL), in reducing all-cause mortality.  Study data suggests the possibility of an ICS/LABA combination product to be of substantial benefit in COPD subjects with less severe airflow obstruction yet with increased cardiovascular risk.

The mechanism by which SFC appears to be associated with a greater reduction in mortality in these less severe COPD subjects with concomitant cardiovascular comorbidities is speculative at present, but could potentially in part be related to a lessening of the degree of inflammation in the systemic circulation, potential plaque stabilization and/or amelioration of arterial stiffness.

The primary objective of this study is to prospectively evaluate the effect of Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25mcg QD compared with placebo on survival in subjects with moderate COPD  and a history of, or at an increased risk for developing, cardiovascular disease.


MEDTRONIC SURESCAN PACING SYSTEM POST APPROVAL STUDY

Status: open and enrolling

Approval Date: 10/7/2011

Objective: Chronic Performance Arm - Subjects enrolled prior to or within 30 days post implant of SureScan pacing system. In office follow-up visits required every 6 months.

Multiple MRI Scan Arm - Subject enrolled into study at the time of MRI Scan indication. Subject followed per clinic's standard of care.

Description: The purpose of this Post-Approval Study (PAS) is to demonstrate the chronic performance of the SureScan pacing system when used in an MRI environment according to product labeling. This study is required by the Food and Drug Administration (FDA) as a condition of product approval. This study is part of the Product Performance Platform (PPP).