Circulation, Vol 78, 60-67, Copyright © 1988 by American Heart Association
EG Nabel, J Barry, MB Rocco, S Campbell, K Mead, T Fenton, EJ Orav and AP Selwyn
Ambulatory electrocardiographic (ECG) monitoring of patients with chronic
stable angina has demonstrated frequent and prolonged episodes of ischemic
ST segment depression, but its clinical use requires an understanding of
the components and extent of variability. Therefore, variations in the
frequency and duration of episodes of ST segment depression were evaluated
with ambulatory ECG recording at daily, weekly, and monthly intervals in 42
patients with chronic stable angina and known coronary artery disease. Data
were analyzed with a nested analysis of variance design that yields
estimates of variance components. From the estimates of variance
components, power calculations and minimum significant percent reductions
in frequency and duration of ischemia were derived. During 4,656 hours of
ambulatory ECG monitoring, 1,262 episodes of ischemic ST segment depression
were detected. The frequency of episodes was 6.3 +/- 0.45/24 hr (mean +/-
SEM), and the duration of episodes was 18.3 +/- 2.8/24 hr. Because of
variability over time, the ability to detect significant changes was
dependent upon the number of subjects, length of monitoring period, and
intervals between monitoring periods. In a clinical trial, for example, a
sample size of 25 patients monitored for 48 hours with 1 week between
control and test conditions would require a 65% reduction in frequency,
whereas a sample size of 50 patients monitored under similar conditions
would require a 46% reduction in frequency, to attribute the change with
90% power to a therapeutic intervention rather than to a spontaneous
variation. When monitoring a single patient for 48 hours with 1 week or 1
month between control and repeat monitoring sessions, episodes of ischemic
ST depression must be eliminated to detect significant therapeutic changes
in ischemic activity at the 95% confidence level.(ABSTRACT TRUNCATED AT 250
WORDS)
ARTICLES
Variability of transient myocardial ischemia in ambulatory patients with coronary artery disease
Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115.
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