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Clinical Trials: Heart


A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When AMG 145 is Used in Combination With Statin Therapy In Patients with Clinically Evident Cardiovascular Disease. FOURIER: Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects With Elevated Risk. (IRB# BH-12-254)

(Heart, Vascular)
  • Principal Investor
    Gregory Giugliano, MD
  • Summary

    This study is for patients aged 40-80 who have had a heart attack or stroke with the past 5 years and

    Have one of the following risk factors:  type 2 diabetes, age 65-80, heart attack or stroke within past 6 months, 2 or more heart attacks or strokes, or history or symptomatic peripheral arterial disease or amputation in addition to a heart attack or stroke. 

    Or

    Have two or more of the following risk factors: history of non-heart attack related coronary revascularization, residual coronary artery disease, HDL-C < 40 mg/dL for men and < 50 mg/dL for women, hsCRP > 2.0 mg/L, final LDL-C > 130 mg/dL or non-HDL-C > 160 mg/dL, metabolic syndrome.

  • Study Site Location
    Baystate Heart and Vascular Research, 3300 Main St. Suite 1D, Springfield, MA
  • Contact
    Annette Scarnici, RN
    413.794.9076
    Email

A Phase II Multi-Center, Parallel-Group, Randomized, Double Blind, Proof-of-Concept, Adaptive Study Investigating the Safety and Efficacy of THR-184 Administered via Intravenous Infusion in Patients at Increased Risk of Developing Cardiac Surgery Associated-Acute Kidney Injury (CSA-AKI) (IRB# 524174)

(Heart, Surgery)
  • Principal Investor
    John Rousou, MD
  • Summary

    The purpose of this study is to see if an investigational medication is effective to prevent acute kidney injury in patients who are undergoing cardiac surgery. 

    Subjects will receive 4 doses in total investigational drug of either THR-184 (2 different dose levels) or placebo.

    Subjects will be followed until 90 Days after surgery for safety measurements.

  • More Information

    Eligibility:

    In order to participate in this trial you must be at least 18 years old and having open heart surgery. 

    Participants must meet eligibility requirements that deem them to be at risk for acute kidney injury post-operatively.

  • Study Site Location
    Baystate Medical Center
  • Contact
    Jennifer Germain, RN, BSN, CCRC
    413.794.2672
    Email

A Post Market Observational Study to Obtain Additional Information on the Use of Cormatrix ECM for Pericardial Reconstruction (IRB# 589061)

(Heart, Surgery)
  • Principal Investor
    David Deaton, MD
  • Summary

    The purpose of this study is to gather additional information on CorMatrix ECM for Pericardial Closure.  This device has received FDA clearance and is intended to close and repair of the sac surrounding the heart during cardiac surgery. To participate in this study, the CorMatrix ECM device must be used during cardiac surgery.

  • Study Site Location
    Baystate Medical Center
  • Contact
    Barbara Burkott, RN, BSN, CCRP
    413.794.1305

Validity of Dyspnea Severity Measure in Acute Heart Failure: Pilot Study (IRB# 293448-23)

(Heart)
  • Principal Investor
    Howard Smithline, MD
  • Summary

    The purpose of this research study is, to see if we can accurately measure the severity of your breathlessness. 

  • More Information

    Eligibility:

    You must be at least 18 years old, admitted to the hospital with congestive heart failure and have shortness of breath.

  • Study Site Location
    Emergency Room Baystate Medical Center
  • Contact
    Kye Poronsky
    413.794.4421
    Email