Title

Frequency of inclusion of patients with cardiogenic shock in trials of thrombolytic therapy.

PubMed ID

8296736

UMMS Affiliation

Meyers Primary Care Institute; Department of Medicine, Division of Geriatric Medicine; Department of Medicine, Division of Cardiovascular Medicine

Date

1-15-1994

Document Type

Article

Medical Subject Headings

Humans; Multivariate Analysis; Myocardial Infarction; Randomized Controlled Trials as Topic; Shock, Cardiogenic; Thrombolytic Therapy; Treatment Outcome

Disciplines

Health Services Research | Medicine and Health Sciences

Abstract

The purpose of this study was to determine the extent to which patients with cardiogenic shock have participated in trials of thrombolytic therapy, to examine factors associated with their exclusion from these trials, and to summarize data on the efficacy of thrombolysis in these patients. Previous publications were searched for all randomized, controlled studies involving the use of thrombolytic medications used in the treatment of acute myocardial infarction. Data were abstracted for year of trial publication, performance location, sample size, maximal allowable delay between symptom onset and treatment, and exclusion criteria. Of the 94 trials included in the analysis, 22% included patients with cardiogenic shock, 37% excluded them, and the remainder contained no information on their inclusion or exclusion. Only 2 trials provided data on the efficacy of thrombolytic therapy in patients with cardiogenic shock. Multivariate analysis revealed that studies conducted exclusively in the U.S. were significantly more likely to exclude patients in cardiogenic shock than those conducted outside of the U.S., as were studies that excluded patients with a previous myocardial infarction, studies published more recently, and smaller trials. Patients with cardiogenic shock have frequently been excluded from clinical trials of thrombolytic agents. As a result, data on the efficacy of thrombolytic agents in these patients is extremely limited.

Rights and Permissions

Citation: Am J Cardiol. 1994 Jan 15;73(2):149-57.

Related Resources

Link to article in PubMed