Abstract / Description: 

This publication describes uniform definitions for cardiovascular and stroke outcomes developed by the Standardized Data Collection for Cardiovascular Trials Initiative and the U.S. Food and Drug Administration (FDA). The FDA established the Standardized Data Collection for Cardiovascular Trials Initiative in 2009 to simplify the design and conduct of clinical trials intended to support marketing applications. The writing committee recognizes that these definitions may be used in other types of clinical trials and clinical care processes where appropriate.

Collection: 
eCardio Hub Collection
Category: 
Clinical trials
Date: 
2018
Author: 
Karen A. Hicks, Kenneth W. Mahaffey, Roxana Mehran, Steven E. Nissen, Stephen D. Wiviott, Billy Dunn, Scott D. Solomon, John R. Marler, John R. Teerlink, Andrew Farb, David A. Morrow, Shari L. Targum, Cathy A. Sila, Mary T. Thanh Hai, Michael R. Jaff, Hylton V. Joffe, Donald E. Cutlip, Akshay S. Desai, Eldrin F. Lewis, C. Michael Gibson, Martin J. Landray, A. Michael Lincoff, Christopher J. White, Steven S. Brooks, Kenneth Rosenfield, Michael J. Domanski, Alexandra J. Lansky, John J.V. McMurray, James E. Tcheng, Steven R. Steinhubl, Paul Burton, Laura Mauri, Christopher M. OíConnor, Marc A. Pfeffer, H.M. James Hung, Norman L. Stockbridge, Bernard R. Chaitman, Robert J. Temple, on behalf of the Standardized Data Collection for Cardiovascular Trials Initiative (SCTI), Heather D. Fitter, Kachikwu Illoh, Kenneth J. Cavanaugh Jr., Benjamin M. Scirica, Ilan Irony, Rachel E. Brown Kichline, Jonathan G. Levine, Anna Park, Leonard Sacks, Ana Szarfman, Ellis F. Unger, Lori Ann Wachter, Bram Zuckerman, Yale Mitchel, Douglas Peddicord, Thomas Shook, Bron Kisler, Charles Jaffe, Rhonda Bartley, David L. DeMets, MariJo Mencini, Cheri Janning, Steve Bai, John Lawrence, Ralph B. DíAgostino Sr. and Stuart J. Pocock