Title

PLATO - A study of PLATelet inhibition and Patient Outcomes.

Sponsor

AstraZeneca, Inc.

Primary Investigator

Robert Weiss, M.D.

Goal

• To evaluate a new therapy for subjects who present with Non-ST Elevation Acute Coronary Syndromes (ACS).

Description

A Randomized, Double-blind, Parallel Group, Phase 3, Efficacy and Safety Study of AZD6140 compared with Clopidogrel for Prevention of Vascular Events in Patients with Non-ST Elevation Acute Coronary Syndromes (ACS).

Status

Enrolling participants

Title

IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE IT)

Sponsor

Schering-Plough Research Institute

Primary Investigator

William Phillips, M.D.

Goal

• To evaluate the clinical benefit of treatment on Cardiovascular (CV) Death, Major Coronary Events, and Stroke

Description

A Multicenter, Double-Blind, Randomized Study to Establish the Clinical Benefit and Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs Simvastatin Monotherapy in High- Risk Subjects Presenting With Acute Coronary Syndrome

Status

Enrolling participants

Title

PRECISION- Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen

Sponsor

Pfizer, Inc

Primary Investigator

William Phillips, M.D.

Goal

The PRECISION Study is designed to assess the effects of

• celecoxib 100-200 mg bid or
• ibuprofen 600-800 mg tid or
• naproxen 375-500 mg bid on the occurrence of Cardiovascular endpoints.

Description

A Randomized, Double Blind, Parallel-Group Study Of Cardiovascular Safety In Osteoarthritis or Rheumatoid Arthritis Patients With or at High Risk for Cardiovascular Disease Comparing Celecoxib With Naproxen and Ibuprofen

Status

Closed to Enrollment at CMMC. Enrolling at Androscoggin Cardiology Associates.

Title

Using Biomarkers to Improve the Prediction of Death for Coronary Artery Bypass Graft Surgery (CABG)

Sponsor

Dartmouth-Hitchcock Medical Center & Northern New England Cardiovascular Disease Study Group

Primary Investigator

Richard Cochran, M.D.

Goal

• Improve pre-operative patient management by following biomarkers that demonstrate myocardial damage, inflammation, and metabolic dysfunction. 
• Predicting higher levels of mortality in patients who are undergoing CABG.

Description

Participants under going CABG donate blood samples pre-operatively and post-operatively from surgical centers throughout northern New England.

Status

Study Closed

Title

Secondary Prevention:  The 1^st 100 CABG Patients

Sponsor

Central Maine Heart and Vascular Institute

Primary Investigator

Richard Cochran, M.D.

Goal

• To determine at one-year after surgery (CABG) how well CMHVI surgical patients are following secondary prevention guidelines. 

Description

Data is being collected based on the American College of Cardiology guidelines for secondary prevention.  This includes:

• Tobacco use
• Blood pressure
• Cholesterol
• Physical activity
• Weight management
• Diabetes management
• Cardiac medication adherence

Status

Study Closed

Title

The Music Intervention Study

Sponsor

Central Maine Heart and Vascular Institute

Primary Investigator

Richard Cochran, M.D.

Goal

• To investigate the effects of a music intervention given twice on the first post-procedure day on noise annoyance, heart rate, and arterial blood pressure.

• To determine sources of noise annoyance in the Single Stay Unit (SSU), assess methods for reduction of noise, and assess the impact on sleep quality.

Description

The effect of music will be assessed on post-surgical and post-interventional levels of noise annoyance and physiological variables (heart rate and arterial pressure) and sleep quality, both before and after unit-wide noise abatement measures.

Status

Study Closed

Title

Aortic Valve Operative Outcomes in Marfan Patients

Sponsor

Baylor College of Medicine & National Marfan Foundation

Primary Investigator

Richard Cochran, M.D.

Goal

• Evaluate prevalence of different types of AVR and AVS operations in patients with Marfan syndrome

• Evaluate indications used to perform AVR and AVS operations

• Estimate: Short-term morbidity and mortality in patients with Marfan syndrome undergoing the AVS or the AVR surgical intervention

• Determine predictors that have prognostic importance for the outcomes of surgical interventions

Description

A multi-center observational intervention follow-up study.

Enrolled participants will have collection of blood and tissue samples, imaging information collected as well as pre- and postoperative, operative and follow-up data.

Status

Study Closed

Title

MEND CABG

Sponsor

Medicure, Inc.

Primary Investigator

Robert Weiss, M.D.

Goal

• To evaluate the effect of MC-1 on the combined incidence of cardiovascular death and nonfatal myocardial infarction (MI) up to and including 30 days following CABG surgery

Description

A Phase III, randomized, double-blind, placebo-controlled, multi-center study to evaluate the cardioprotective effects of MC-1 in patients undergoing high-risk CABG

Status

Study Closed

Title

The ACUITY Trial: A randomized comparison of Angiomax^R (bivalirudin) versus Lovenox^R/Clexane^R (enoxaparin) in patients undergoing early invasive management for acute coronary syndromes without ST-segment elevation

Sponsor

The Medicine’s Company       

Primary Investigator

William Phillips, M.D.

Goal

The ACUITY trial is designed to show that, when compared with enoxaparin and routine GPIIb/IIIa inhibition:

1) Bivalirudin with routine GPIIb/IIIa inhibition provides non-inferior or superior overall clinical outcomes and

2) Bivalirudin alone reduces clinically significant bleeding. An important secondary objective for this comparison is to show that bivalirudin is not inferior for ischemic complications.

An important secondary objective, which will be examined by separate randomization, is to compare clinical outcomes following GPIIb/IIIa inhibition given to all patients upfront prior to angiography vs. selective use of GPIIb/IIIa inhibition in patients undergoing PCI only.

Description

Patients with acute coronary syndromes without ST elevation on ECG with intermediate or high risk factors (TIMI risk score 3-7, new or dynamic ST segment deviation, or elevation of cardiac enzymes (troponin-T, troponin-I or CPK-MB) at the time of presentation) will be enrolled.

Status

Completed

Title

Contemporary Analysis of Peri-operative Cardiovascular Surgical Care (CAPS Care)

Sponsor

The Society of Thoracic Surgeons      

Primary Investigator

Richard Cochran, M.D.

Goal

• To identify standard practices in the early peri-operative setting of high risk cardiac surgery patients.

Description

Via retrospective chart review, data will be collected.  This includes pre-operative clinical status (labs, EKG and home medications), intra-operative anticoagulant and diabetic management and post operative management (pharmacological, arrhythmia, cardiac markers and related cardiac events). 

Status

Completed

Title

Epidemiologic International Day for the Evaluation of Patients at Risk of Venous Thrombosis in the Acute Hospital Care Setting (ENDORSE)

Sponsor

Center for Outcomes Research at the University of Massachusetts Medical School

Primary Investigator

Bruce Condit. M.D.

Goal

• To identify patients at risk for venous thromboembolism (VTE) among medical and surgical patients hospitalized in selected wards in representative hospitals throughout the world; and

• To determine the proportion of at-risk hospitalized patients who receive effective types of VTE prophylaxis.

Description

Via chart review, data will be collected.  This includes:

• Detailed history of medical risk factors for VTE

• Type of major surgical procedure performed or major medical illness present on admission or during the first 14 days of hospitalization

• Day since hospital admission (up to day 14) on which the surgical procedure/major medical illness was recorded in the chart

• Risk factors for bleeding present during the first 14 days of hospitalization

• Presence and timing of occurrence of additional risk factors for VTE present immediately prior to admission or during the first 14 days of hospitalization

• Type, dose, and frequency of VTE prophylaxis ordered and the day of hospitalization on which it was initiated and/or terminated

• Presence/absence of therapeutic anticoagulation and the day of hospitalization on which it was initiated/terminated

Status

Completed

Title

Vascular Study Group Registries

Sponsor

Northern New England (NNE) Vascular Study Group

Primary Investigator

Pam Rietschel, M.D. & Allan Ingraham, M.D.

Description

Participation in voluntary data registries for vascular surgery to assess efficacy and methods of treatment for vascular intervention

Title

Cardiovascular Disease Study Group Registries

Sponsor

Northern New England (NNE) Cardiovascular Disease Study Group

Primary Investigator

Richard Cochran, M.D., William Phillips, M.D

Description

Participation in voluntary data registries for cardiac surgery and cardiology intervention, to assess efficacy and methods of treatment for cardiovascular intervention

Title

Interventional Cardiology Registry

Sponsor

American College of Cardiology

Primary Investigator

William Phillips, M.D.

Description

Participation in voluntary data registry for interventional cardiology, to evaluate outcomes, with regional and national benchmarking

Title

Cardiovascular Surgery Registry

Sponsor

Society of Thoracic Surgery

Primary Investigator

Richard Cochran, M.D.

Description

Participation in voluntary data registry for cardiac surgery, to evaluate outcomes, with regional and national benchmarking.

Title

ICD

Sponsor

American College of Cardiology- National Cardiovascular Data Registry

Primary Investigator

Daniel Soroff, M.D.

Description

Participation in this registry is required to meet CMS data collection requirements for reimbursement for ICD implantation.  We receive quarterly benchmark reports that can be used to measure patient outcomes, volume and utilization.