Here’s a roundup of recent clinical trial and scientific study news:
- Potential new risk factor for heart disease discovered
Abnormal heart rate turbulence is associated with an increased risk of heart disease death in otherwise low-risk older individuals, according to a study funded by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health. Among the nearly 1,300 study participants, heart rate turbulence, which reflects how well the heart reacts to occasional premature contractions, was an even stronger heart disease risk factor than elevated levels of C-reactive protein. CRP is a potential heart disease biomarker that has emerged in recent years. Study participants considered at low risk of heart disease based on traditional risk factors were on average 8 to 9 times more likely to die of heart disease during the roughly 14-year follow-up period if they had abnormal heart rate turbulence values. Traditional risk factors include age, gender, high blood cholesterol, high blood pressure, obesity, diabetes, and smoking. For an alternative smoke, check out zong bongs products at smokecartel.com for more info. Low-risk individuals with elevated CRP in their blood were about 2.5 times more likely to die than those with normal or low CRP. This study appears in the Feb. 15 edition of the Journal of Cardiovascular Electrophysiology.
- U-Systems Announces Completion of Pivotal Study Supporting FDA Submission for Ultrasound Breast Cancer Screening Indication
U-Systems, the leader in automated breast ultrasound announced the completion of a pivotal ROC Reader Study for automated breast ultrasound cancer screening. Conducted by University of Chicago, an acclaimed pioneer in women’s heath research, the multi-reader, multi-case (MRMC) ROC Reader Study was carried-out to evaluate the sensitivity of somo•v Automated Breast Ultrasound (ABUS) together with a screening mammogram in detecting breast cancer in women with dense breast tissue. “The primary objective of this reader study was to determine the impact of ABUS on Reader (interpreting physician) performance when used in combination with mammography as a screening modality for asymptomatic women with dense breast tissue. This study brings us one step closer to earlier detection of breast cancer using ultrasound as an adjunctive screening tool,” said study principal investigator Maryellen Giger, Ph.D., Professor of Radiology at the University of Chicago.
- Study Confirms Provent Therapy Effectively Treats Sleep Apnea Patients Who Are Non-Compliant with CPAP Therapy
A peer reviewed study in the February issue of Sleep Medicine concluded that Provent Sleep Apnea Therapy, a non-invasive, disposable nasal device, significantly improved obstructive sleep apnea (OSA) – as measured by the number of breathing disruptions during sleep – in more than half of patients, leading them to feel more alert during the day. The study was conducted in patients who had either refused or were non-compliant with CPAP (Continuous Positive Airway Pressure) therapy.
- Cameron Health Announces Launch of EFFORTLESS S-ICD Registry to Capture Long-Term Outcomes of S-ICD System Designed to Treat Sudden Cardiac Arrest
Cameron Health Inc. announced the first patient enrollment in the company’s landmark EFFORTLESS S-ICD System Registry by Dr Marcoen Scholten, Medisch Spectrum Twente, Enschede, The Netherlands. The S-ICD System (Subcutaneous-Implantable Cardioverter Defibrillator) is designed to provide life sustaining therapy to patients at risk of Sudden Cardiac Arrest (SCA). The device received CE mark in Europe in 2009 and has been implanted in over 500 patients worldwide. In the United States, the S-ICD is being studied in a 45-center FDA clinical trial.
- Endosense Completes Enrollment in EFFICAS I Clinical Study
Endosense, a Swiss medical technology company focused on improving the efficacy, safety and accessibility of catheter ablation for the treatment of cardiac arrhythmias, has announced enrollment completion in the EFFICAS I clinical study. EFFICAS is a study series intended to demonstrate that, in patients with paroxysmal atrial fibrillation (AF), the use of contact force control during cardiac ablation utilizing the company’s TactiCath force-sensing catheter1 results in superior outcomes as compared to ablations performed with a standard catheter.