UAB has a long tradition of excellence in multi-center clinical trials in cardiovascular medicine and trauma, as described below. 

 

Cardiac Arrhythmia Suppression Trial (CAST)

OBJECTIVE: To test the hypothesis that in survivors of myocardial infarction, the suppression of ventricular premature depolarizations improves survival free of cardiac arrest and arrhythmic death.

DESIGN: International, prospective, multicenter, randomized, placebo-controlled trial.

SETTING: University and community hospitals.

PATIENTS: A total of 3549 patients with myocardial infarction and left ventricular dysfunction. INTERVENTION: Administration of encainide, flecainide, moricizine, or placebo to suppress ventricular premature depolarizations.

MAIN OUTCOME MEASURES: Overall survival and survival free of cardiac arrest or arrhythmic death were compared in patients randomized to long-term, active antiarrhythmic drug therapy vs corresponding placebo, using the stratified log rank statistic.

RESULTS: At 1 year from the time of randomization to blinded therapy, 95% of placebo-treated patients vs 90% of active drug-treated patients remained alive (P = .0006). Similarly, at 1 year, 96% of placebo-treated patients vs 93% of active drug-treated patients remained free of cardiac arrest or arrhythmic death (P = .003).

CONCLUSIONS: The suppression of asymptomatic or mildly symptomatic ventricular arrhythmias after myocardial infarction does not improve survival and can increase mortality. Treatment strategies designed solely to suppress these arrhythmias should no longer be followed.

REFERENCE: JAMA Vol. 270 No. 20, November 24, 1993

 

Enhancing Recovery in Coronary Heart Disease (ENRICHD) Patients Trial

OBJECTIVE: Depression and low social support are risk factors for medical morbidity and mortality after acute MI. The ENRICHD study is a multicenter, randomized, controlled clinical trial of a cognitive-behavioral treatment for depression and low social support in post-MI patients. A total of 2481 patients were recruited (26% with low social support, 39% with depression, and 34% with low social support and depression). Our objective is to describe the rationale, design, and delivery of the ENRICHD intervention.

METHODS: Key features of the intervention include the integration of cognitive-behavioral and social learning approaches to the treatment of depression and a diverse set of problems that can contribute to low social support; rapid initiation of treatment after MI; a combination of individual and group modalities; adjunctive pharmacotherapy for severe or intractable depression; training, certification, and supervision of therapists; and quality assurance procedures.

RESULTS: The trial’s psychosocial and medical outcomes will be presented in future reports.

CONCLUSIONS: The ENRICHD protocol targets two complex psychosocial risk factors with a multifaceted intervention, which is delivered in an individualized manner to accommodate a demographically, medically, and psychiatrically diverse patient population. Additional research will be needed to identify optimal matches between patient characteristics and specific components of the intervention.

REFERENCE: Psychosomatic Medicine 63:747-755 (2001)

 

Rapid Early Action for Coronary Treatment (REACT) Trial

ABSTRACT: Coronary heart disease (CHD) remains the leading cause of mortality in the U.S. Innovations in reperfusion therapies can potentially reduce CHD morbidity and mortality associated with acute myocardial infarction (AMI) when treatment is initiated within the first few hours of symptom onset. However, delay in seeking treatment for AMI is unacceptably lengthy, resulting in most patients being ineligible for reperfusion therapies. The Rapid Early Action for Coronary Treatment (REACT) Trial is a four-year, 20-community, randomized trial to design and test the effectiveness of a multi-component intervention to reduce patient delay for hospital care-seeking for AMI symptoms. This manuscript describes the development and content of the theoretically-based REACT intervention and summarizes: (1) the research literature used to inform the intervention; (2) the behavioral theories used to guide the development, implementation, and evaluation of the intervention; (3) the formative research undertaken to understand better decision-making processes as well as barriers and facilitators to seeking medical care as perceived by AMI patients, their families, and medical professionals; (4) the intervention design issues that were addressed; (5) the synthesis of data sources in developing the core message content; (6) the conceptualization for determining the intervention target audiences and associated intervention components and strategies, their integration with guiding theoretical approaches and implementation theories for the study, and a description of major intervention materials developed to implement the intervention; and (7) the focus of the outcome, impact, and process measurement based on the intervention components and theories on which they were developed.

REFERENCE: American Journal of Preventive Medicine, Volume 16, Number 4, May 1999, pp. 325-334(10)

 

Thrombolysis in Myocardial Infarction (TIMI) Trials

There have been more than 30 TIMI trials over the past 15-20 years, and the trials are still continuing. UAB has chosen to participate in some, but not all, of the trials.  The design of most of the TIMI trials and other informative materials related to the TIMI trials can be found at www.timi.org.

 

Multicenter Traumatic Brain Injury Clinical Trials Network

Traumatic brain injury (TBI) is a major public health problem for the United States with an incidence of over 500,000 cases admitted to hospital annually. Few proven therapies for TBI exist and the prognosis for individuals with moderate to severe TBI remains grim. Progress in improving outcomes for individuals with TBI depends upon prevention and on the continued development of better therapeutic regimens in all aspects of care. The TBI-CT Network is an efficient and cost-effective organization, serving as a major source of evidence-based trauma and rehabilitative medicine through the conduct of multi-center clinical studies in TBI and through the dissemination of research results.

 REFERENCE: Journal of Head Trauma Rehabilitation. 18(1):5-6, January/February 2003.

 

Public Access to Defibrillation (PAD) Trial

BACKGROUND: The rate of survival after out-of-hospital cardiac arrest is low. It is not known whether this rate will increase if laypersons are trained to attempt defibrillation with the use of automated external defibrillators (AEDs).

METHODS: We conducted a prospective, community-based, multicenter clinical trial in which we randomly assigned community units (e.g., shopping malls and apartment complexes) to a structured and monitored emergency-response system involving lay volunteers trained in cardiopulmonary resuscitation (CPR) alone or in CPR and the use of AEDs. The primary outcome was survival to hospital discharge.

RESULTS: More than 19,000 volunteer responders from 993 community units in 24 North American regions participated. The two study groups had similar unit and volunteer characteristics. Patients with treated out-of-hospital cardiac arrest in the two groups were similar in age (mean, 69.8 years), proportion of men (67 percent), rate of cardiac arrest in a public location (70 percent), and rate of witnessed cardiac arrest (72 percent). No inappropriate shocks were delivered. There were more survivors to hospital discharge in the units assigned to have volunteers trained in CPR plus the use of AEDs (30 survivors among 128 arrests) than there were in the units assigned to have volunteers trained only in CPR (15 among 107; P=0.03; relative risk, 2.0; 95 percent confidence interval, 1.07 to 3.77); there were only 2 survivors in residential complexes. Functional status at hospital discharge did not differ between the two groups.

CONCLUSIONS: Training and equipping volunteers to attempt early defibrillation within a structured response system can increase the number of survivors to hospital discharge after out of-hospital cardiac arrest in public locations. Trained laypersons can use AEDs safely and effectively.

REFERENCE: New England Journal of Medicine 2004;351:637-46.

 

Rural Access to Emergency Devices

A promising initiative funded by HRSA’s Office of Rural Health Policy, “Rural Access to Emergency Devices” is a series of studies and implementation strategies for addressing OOH-CA.  In collaboration with the Alabama Department of Public Health, Dr. Terndrup serves as the outcomes research co-PI.  Currently in its second of an expected four years, the study extends the benefits of CPR and AED implementation to all remaining 460,000 Alabamians living in sixteen rural counties.  Funding will allow a nearly state-wide implementation of access to CPR/AED.  In addition, the study collects standardized data on OOH-CA victims, consistent with the Utstien criteria, by having rescuers dictate several of these variables into the microphone of each AED where the information is recorded.  Data from OOH-CA events are then transmitted from volunteer fire fighter locations by modem to an 800-line at UAB.  Data is encrypted and backed up to maintain confidentiality and data integrity.  Each AED application on a new patient requires a new set of pads which are provided by the regional EMS offices.  When a volunteer fire department utilizes the AED, they are supplied with replacement pads maintained by their regional EMS office.  At the time that the pads are replaced, the regional office performs a brief interview to ensure program compliance and safety, and to perform any needed educational remediation.  Data quality and analysis are coordinated at UAB in order to evaluate the impact of training and AED placement in rural communities.  Clinical outcomes, including survival to hospital discharge and neurological measures, are being measured to establish the impact of this intervention.