CCS has extensive clinical research experience in all major cardiovascular disease targets for drugs and devices; comprising therapeutic, diagnostic and core laboratory trials; in all clinical settings. We have conducted trials in the following common disease targets:
- Acute Coronary Syndrome
- Chronic Angina
- Heart Failure
- Interventional Cardiology
CCS has evolved highly specialized clinical service capabilities in:
- adjudication of cardiovascular end points (e.g., CECs),
- hemodynamic trials,
- clinical imaging and core laboratory trials,
- follow-on trials and phase IV registries with cardiovascular event and quality of life outcomes;
- cardiac nurse call center;
- pharmacoeconomic studies including cost-effectiveness, reimbursement modeling and profitability impact studies of cardiovascular interventions.
CCS Heart Failure Experience
Marvin Konstam, MD, Chief Scientific Officer at CCS, is past president of the Heart Failure Society of America, and has presented and published the results of numerous major heart failure trials at national and international meetings and in major journals such as JAMA and CIRCULATION, for such studies as the EVEREST trial of tolvaptan presented at the late breaking trials session at the american college of cardiology annual meeting 2007 and published simultaneously in JAMA.
James Udelson, MD, Chief Medical Officer at CCS, co-director of the heart failure program at Tufts-NEMC, and has also presented and published results of numerous heart failure trials, such as the results on the METEOR trial of remodeling effects of tolvaptan at the annual meeting of the American Heart Association 2006 and published recently in JACC.
Patricia Wedge, RN, CCRP, Vice President of Clinical Operations at CCS, has been project manager or project leader on over 20 heart failure trials over the last 15 years and is a heart failure nurse who still conducts a weekly heart failure clinic with Dr. Konstam.
Doug Dowling, General Manager of Cardiovascular Core Laboratories, has served as core lab project manager on numerous imaging trials including sestamibi, a biologic for treating familial amyloid cardiomyopathy, regenerative therapies for MI- related cardiomyopathy, etc.
Douglas Gregory, PhD, CEO of CCS, has been first author on a number of publications on the pharmacoeconomics of heart failure in such journals as JACC, AHJ, CIRC, AMJ and serves as a member of the Care Standards Committee of the Heart Failure Society of America.
Kathleen Perry, BSN, has 20 years experience as a critical care nurse, director of a heart failure disease management program at Tufts-NEMC, clinical project coordinator and clinical quality control reviewer for Clinical Event Committees at CCS.
Lynne Dugan, BSN, has 10 years experience as a hospital cardiovascular imaging nurse, heart failure disease management program coordinator and study coordinator; and as an associate project manager and clinical quality control reviewer for Clinical Event Committees at CCS.
Select Heart Failure Studies
6 studies of Tolvaptan in heart failure over 5 years:
3 studies of Conivaptan in heart failure
- 2 studies in chronic stable heart failure
- 1 remodeling study with Radio Ventriculogram (METEOR)
- 1 PK/PD
- 1 global study in acute decompensated heart failure(EVEREST),
- 1 global Hemodynamic (ECLIPSE)
- 1 chronic stable heart failure exercise tolerance/VO2 max,
- 1 chronic stable heart failure hemodynamic study,
- 1 remodeling study with cardiac MR stable, chronic heart failure
1 study of Eplerenone in chronic stable heart failure
1 study of Sestamibi imaging in heart failure
1 study of Amlodipine in chronic heart failure
2 studies of COREG-CR:
2 regenerative therapy studies in post myocardial infarction cardiomyopathy
1 study of a biologic in familial amyloid cardiomyopathy
study of an adenosine antagonist in acute decompensated heart failure
Click here to view charts of CCS's services on the above studies.