The American journal of cardiology
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Randomized Controlled Trial Multicenter Study Clinical Trial
Effect of extended-release isosorbide mononitrate one hour after dosing in patients with stable angina pectoris. IMDUR Study Group.
The effect of extended-release isosorbide mononitrate (ER-ISMN) on exercise tolerance 1 hour after dosing was compared with that of placebo in a multicenter, randomized, double-blind study of 151 patients with stable effort-induced angina. During a 9- to 24-day placebo run-in, patients underwent Bruce protocol baseline exercise tolerance tests, after which they received ER-ISMN or placebo for 5 days. ER-ISMN patients took 60 mg each morning for the first 4 days and 120 mg on the morning of the fifth day. ⋯ Treatment-related adverse events were reported in 37% (28 of 75) and 7% (5 of 76) of patients in the ER-ISMN and placebo groups, respectively. As expected, headache was more frequent in the ER-ISMN group than in the placebo group (28% and 1%, respectively). The effects of ER-ISMN (60 mg and 120 mg) are clinically evident 1 hour after dosing, resulting in better exercise tolerance in patients with angina pectoris.
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Clinical Trial
Feasibility, accuracy, and incremental value of intraoperative three-dimensional transesophageal echocardiography in valve surgery.
In this prospective trial, intraoperative 2-dimensional (2-D) and 3-dimensional (3-D) transesophageal echocardiography (TEE) examinations were performed on 60 consecutive patients undergoing cardiac valve surgery. Both 2-D (including color flow and Doppler data) and 3-D images were reviewed by blinded observers, and major valvular morphologic findings recorded. In vivo morphologic findings were noted by the surgeon and all explanted valves underwent detailed pathologic examination. ⋯ In several instances, 3-D echocardiography provided complementary morphologic information that explained the mechanism of abnormalities seen on 2-D and color flow imaging. In the reproducibility subset, preoperative and intraoperative 3-D imaging detected a similar number of findings when compared with pathology. Thus, in routine clinical intraoperative settings, 3-dimensional TEE is feasible, accurately predicts valve morphology, and provides additional and complementary valvular morphologic information compared with conventional 2-D TEE, and is probably reproducible.
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Randomized Controlled Trial Clinical Trial
Prognostic significance of myocardial ischemia detected by ambulatory electrocardiography, exercise treadmill testing, and electrocardiogram at rest to predict cardiac events by one year (the Asymptomatic Cardiac Ischemia Pilot [ACIP] study)
Myocardial ischemia identified by ambulatory electrocardiography (AECG), exercising treadmill testing, (ETT), or 12-lead electrocardiogram at rest is associated with an adverse prognosis, but the effect of improving these ischemic manifestations by treatment on outcome is unknown. The Asymptomatic Cardiac Ischemia Pilot (ACIP) study was a National Heart, Lung, and Blood Institute funded study to determine the feasibility of conducting a large-scale prognosis study and to assess the effect of 3 treatment strategies (angina-guided strategy, AECG ischemia-guided strategy, and revascularization strategy) in reducing the manifestations of ischemia as indicated by AECG and ETT. The study cohort for this database study consisted of 496 randomized patients who performed the AECG, ETT, and 12-lead electrocardiogram at rest at both the qualifying and week 12 visits. ⋯ The medical treatment strategies only slightly improved the exercise time and the exercise duration remained of prognostic significance. In the revascularization group strategy patients this association was absent. Thus, myocardial ischemia detected by AECG and an abnormal ETT are each independently associated with an adverse cardiac outcome in patients subsequently treated medically.