Validation of a digitized Holter monitoring system by comparison with the Marquette Case system

The Nifedipine Gastro-Intestinal Therapeutic System (GITS) Circadian Anti-ischemia Program (N-CAP) was designed to test the effect of nifedipine GITS as monotherapy or in combination with a beta-adrenergic blocking agent on the circadian pattern of angina and silent ischemia in patients with chronic stable angina. At 118 sites in the United States, 1,174 patients were screened for entry into this study. To be eligible for participation patients were required to have at least two episodes of angina a week and at least two episodes of myocardial ischemia during 48-h ambulatory electrocardiographic (ECG) monitoring during the baseline placebo period. A total of 207 patients completed all phases of the study. Beta-blockers were continued in those patients already receiving them. In this 7- to 10-week single-blind placebo withdrawal study, a 1-week placebo run-in was followed by up to 5 weeks of single-blind titration with nifedipine GITS, a 4-week efficacy phase with an established dose and a final single-blind 2-week placebo withdrawal period. Ambulatory ECG monitoring was performed at the end of each placebo phase and at the end of the efficacy phase with a digital monitoring device that was validated in a pilot study. Overall, nifedipine GITS significantly reduced the weekly number of anginal episodes from 5.7 to 1.8 (p = 0.0001) and the number of ischemic events from 7.3 to 4 (p = 0.0001) reported during the 48-h monitoring periods, with a significant increase in both during the placebo withdrawal period. The baseline circadian pattern of ischemia showed an early morning peak and a secondary peak in the afternoon. Nifedipine GITS significantly reduced ischemia during the 48-h period when administered as monotherapy or in combination with a beta-blocker. Patients were also randomized to receive nifedipine GITS in either a morning or an evening dose. The two regimens resulted in equal anti-ischemic benefit. The primary side effect of nifedipine GITS was edema, which was dose related. In summary, nifedipine GITS reduced the number of anginal and ischemic episodes when given alone or in combination with a beta-blocker. Nifedipine GITS had a sustained effect: a single daily dose was effective over 24 h regardless of whether it was administered in the morning or evening. This study also suggests that combination therapy with nifedipine GITS and a beta-blocker is especially efficacious in reducing ischemia.

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Attenuation of the circadian patterns of myocardial ischemia with nifedipine GITS in patients with chronic stable angina

Parmley

Nesto

Singh

et al. 1992

Journal of the American College of Cardiology

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Validation testing of the SEER real-time digital holter monitor

London

1996

Journal of Cardiothoracic and Vascular Anesthesia

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Clinical Assessment of a New Method for Pacing Pulse Detection Using a Hybrid Circuit in Digital Holter Monitoring

et al. 2000

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Holter monitoring is widely used for the detection of arrhythmia and ischemic episodes. Traditionally, analog amplitude-modulated Holter devices have been used for detecting arrhythmia, but they produce signal distortion due to contour effects and phase distortion caused by the tape recorders. A digital Holter device without these disadvantages has been developed and can reproduce clinically accurate electrocardiographic waveforms useful for assessment of arrhythmia and ST segments. However, their reliability is questionable when detecting pacing pulses in pacemaker patients. Because electrocardiographic signals are digitized based on sampling rate, pacing pulses are occasionally missed. Therefore, the FM-300 was developed, a new device for detecting pacing pulses on digital recordings that has both digital and analog circuits in one system and indicates pacing pulse timing with arrows. This device can automatically detect and recognize pacing pulses from various artifacts and pacing modalities, making it easy to identify pacing pulses on digitally recorded electrocardiograms. The FM-300 is useful in the diagnosis and assessment of pacemaker function and has improved the reliability of pulse detection in digital Holter monitoring.

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Validation of a digitized Holter monitoring system by comparison with the Marquette Case system

Cited by 3 publications

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Attenuation of the circadian patterns of myocardial ischemia with nifedipine GITS in patients with chronic stable angina

Attenuation of the circadian patterns of myocardial ischemia with nifedipine GITS in patients with chronic stable angina

Validation testing of the SEER real-time digital holter monitor

Clinical Assessment of a New Method for Pacing Pulse Detection Using a Hybrid Circuit in Digital Holter Monitoring

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