Therapeutic Area: Heart Failure

Principal Investigator:  Joseph Dell’Orfano, M.D.

Title: Impedance Monitoring Study Summary, St. Jude Medical

Description: We are undertaking a research study designed to collect and analyze intra-thoracic impedance measurements in a heart failure population with a standard CRT-D indication. The primary objective is to determine the impedance vector(s) that correlate best with decompensated heart failure events. The devices include a diagnostic Impedance Monitoring feature, a data collection algorithm that continuously collects intra-thoracic impedance measurements from up to six different lead configurations, at programmable intervals(e.g., every 2 hours)

Eligible patients: Subject must have an approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D device, have been implanted with a SJM CRT-D system capable of enabling the impedance monitoring, At least one hospitalization, emergency department visit, or clinic visit within the past 12 months for treatment of decompensated heart failure requiring intravenous diuretics, intravenous inotropes, Natrecor (Nesiritide) therapy, or an increase in an oral diuretic of =100% over a 24 hour period, The ability to maintain a patient diary for recording daily weights, symptoms related to HF, and changes in diuretic therapy

Excluded patient:  Who have had CABG within 40 days of enrollment, a recent myocardial infarction, unstable angina or cardiac revascularization (PTCA/stent(s), have had a recent CVA or TIA within three months of enrollment,an indication for programming device in AAI pacing mode

Length/Duration: 60 patients nationwide.  1 year follow-up visits every 3  months.

Location: Saint Francis Hospital and Medical Center/Hoffman Heart Institute

Point of Contact for Information Regarding Patient Benefits and to Learn if You Qualify: Kathleen Woods, RN at (860) 714-5894.

Therapeutic Area: Acute Coronary Syndrome

Principal Investigator:  Mike Therrien, M.D.

Title: Improve-It

Description: We are undertaking a research study designed to establish the incremental clinical benefit and safety of ezetimibe (administered as part of Ezetimibe/Simvastatin Combination 10/40 tablet, a single tablet containing ezetimibe 10 mg and simvastatin 40 mg) compared with simvastatin monotherapy in high-risk coronary artery disease subjects and aims to address the fundamental question of whether ezetimibe-mediated incremental reductions of LDL-C will translate into a clinical benefit.  Eligible subjects will receive randomized, double-blind treatment assignment in a 1:1 ratio to either Ezetimibe/Simvastatin Combination 10/40 or simvastatin 40 mg QD. Study drug will be administered once daily in the evening.

Eligible patients: Subject must have NSTE-ACS or STEMI, Statin-naïve subject will be eligible to enroll if his/her LDL-C concentration is >50 mg/dL and <125 mg/dL, Subject receiving chronic statin therapy will be eligible to enroll, if his/her LDL-C concentration is >50 mg/dL and <100 mg/dL
Excluded patient: Subject who is clinically unstable, Subject has active liver disease or persistent unexplained serum transaminase elevations, The discontinuation of existing stain regimen poses a risk to the subject. Receiving statin therapy with LDL-C lowering potency greater than simvastatin 40 mg (eg, atorvastatin 40–80 mg, all doses of rosuvastatin, and all doses of Ezetimibe/Simvastatin Combination)

Length/Duration: 10,000 patients worldwide.  2.5 years of treatment follow-up visits every 4  months.

Location: Saint Francis Hospital and Medical Center/Hoffman Heart Institute

Point of Contact for Information Regarding Patient Benefits and to Learn if You Qualify: Kathleen Woods, RN at (860) 714-5894.

Therapeutic Area: Sudden Cardiac Death

Principal Investigator:  Aneesh Tolat, M.D.

Title: Vital Protocol

Description: We are undertaking a research study evaluating the sensitivity of the PD2i cardiac analyzer in predicting risk for sudden cardiac death.  Patients will receive an extended 12 lead ECG that last about 40 minutes.  This ECG will be analyzed with proprietary software for changes that may predict Sudden Cardiac death.

Eligible patients: LVEF <35% in past 6 months, Prior myocardial infarction, NYHA Class II,III or IV, Referred for EP testing and/or ICD implantation

Excluded patient: Current Atrial Fibrillation, History of cardiac arrest due to arrhythmia, taking anti-arrhythmic medications, cardiac surgery or cardiac stenting anticipated in the next 30 days

Length/Duration: 900 patients nationally.  1 year of patient follow-up with visits at 6 and 12 months.

Location: Saint Francis Hospital and Medical Center/Hoffman Heart Institute

Point of Contact for Information Regarding Patient Benefits and to Learn if You Qualify: Kathleen Woods, RN at (860) 714-5894.

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