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Cardiology Research

Study Title: US-based, Observational, Drug Registry Opsumit® (macitentan) new users in clinical practice (OPUS) (Identifier: NCT02126943)

Study Purpose:  Prospective observational drug registry developed to characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with Opsumit® in the post-marketing setting

Principal Investigator: Samer Khouri, M.D.

Study Coordinator:  For more information email Stephanie Frank, RN, or call 419.383.3853


Study Title:   Myocardial Ischemia and Transfusion (MINT).  (Identifier: NCT02981407)

Study Purpose:  The purpose of this study is to compare two red blood cell transfusion strategies (liberal and restrictive) for patients who have had an acute myocardial infarction and are anemic.

Principal Investigator: Mujeeb Sheikh, M.D.

Study Coordinator:  For more information email Stephanie Frank, RN, or call 419.383.3853


Study Title:   The Randomized and Controlled Noninferiority Trial to Evaluate Safety and Clinical Efficacy of the SurVeil Drug-Coated Balloon in the Treatment of Subjects with Stenotic Lesions of the Femoropopliteal Artery Compared to the Medtronic IN.PACT® Admiral® Drug-Coated Balloon (TRANSCEND Study).  (Identifier: NCT03241459)

Study Purpose:  This trial will evaluate the safety and effectiveness of a newly developed drug-coated balloon (DCB) catheter, the Surmodics SurVeil DCB, in the treatment of narrowing within an artery in the thigh.  The study will test how well the SurVeil DCB catheter performs in treating this narrowing compared to the Food and Drug Administration (FDA) approved Medtronic IN.PACT Admiral DCB catheter.

Principal Investigator: Mark Burket, M.D.

Study Coordinator:  For more information email Stephanie Frank, RN, or call 419.383.3853


Study Title: Retrospective and prospective international EKoSoNic® registry Of the treatment and Clinical OUTcomes of patients with pulmonary embolism – KNOCOUT PE (Identifier: NCT03426124)

Study Purpose: To understand the APT treatment protocol used as SoC across institutions and document changes in practice following the OPTALYSE PE study results. To describe the effects of varied APT protocols on long-term patient outcomes.

Principal Investigator: Rajesh Gupta, M.D.

Study Coordinator: For more information email Stephanie Frank, RN, or call 419.383.3853


Study Title: A phase III randomised, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with preserved Ejection Fraction (HFpEF).(Identifier: NCT03057951)

Study Purpose: To demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF > 40%) under stable treatment of HF symptoms.

Principal Investigator: Samer Khouri, M.D.

Study Coordinator: For more information email Stephanie Frank, RN, or call 419.383.3853


Study Title: A phase III randomised, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with reduced Ejection Fraction (HFrEF). (Identifier: NCT03057977)

Study Purpose: to demonstrate superiority of empagliflozin 10 mg versus placebo on top of guideline-directed medical therapy in patients with symptomatic, chronic HF and reduced ejection fraction (LVEF ≤ 40%).

Principal Investigator: Samer Khouri, M.D.

Study Coordinator: For more information email Stephanie Frank, RN, or call 419.383.3853

Last Updated: 4/23/19