| 1. |
- Johanson, Per, 1963, et al.
(författare)
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An academic ECG core lab perspective of the FDA initiative for digital ECG capture and data management in large-scale clinical trials
- 2005
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Ingår i: Drug Information Journal. - 0092-8615. ; 39:4, s. 345-351
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Tidskriftsartikel (refereegranskat)abstract
- Maximal utility of accessible data is attractive to all partners in clinical research, whether it directly improves patient care or more accurately allows identification of the safety and efficacy of a new drug or procedure. The Food and Drug Administration (FDA) has presented a guideline draft addressing digitization of electrocardiogram (ECG) data in clinical trials to improve the standards for collection, analysis, and storage of safety information on new medical therapies. This FDA initiative has led to discussions and collaboration among the FDA, the pharmaceutical industry, the electrocardiographj, manufacturers, and the academic as well as the nonacademic EGG core labs. In this article, we present a broad-based viewpoint from two groups of academic EGG core labs, the Alliance of Academic EGG Core Labs and the Virtual Electronic EGG Corelab International Consortium. We have chosen to widen the perspective from using digitized EGG data in safety trials only, as addressed by the FDA guideline draft, to a discussion on the possibilities and the potential problems when using digitized EGG data also in large clinical trials focusing on efficacy measurements. We conclude that the benefit of digital data mining is probably well worth an initial incremental effort and expense.
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| 2. |
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| 3. |
- Johanson, Aki, et al.
(författare)
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Long-term follow-up in depressed patients treated with ECT
- 2005
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Ingår i: Journal of ECT. - 1533-4112. ; 21:4, s. 214-220
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Tidskriftsartikel (refereegranskat)abstract
- Design: The aim was to study the long-term effects of electroconvulsive therapy (ECT) in depression. 55 patients were followed-up 20-24 years after an ECT series. 13 patients were still alive and 10 agreed to participate in the study. All 55 patients had been investigated with clinical and neuropsychological assessment and with neurophysiological measurements; regional Cerebral Blood Flow (rCBF) and EEG before the first ECT, six months later and after about one year. These investigations were now repeated in the 10 patients. Results: Before the original ECT series all patients had suffered from severe mood disorder. At the follow-up the 10 patients showed no clear signs of mood disorder or cognitive impairment. There was a slightly subnormal performance in working memory and in verbal as well as visual episodic memory on all three occasions after the ECT series. The rCBF measurement showed a significant average CBF decrease from the first to the last measurement. There was, moreover, a significant rCBF decrease in frontal areas at the last measurement compared to the three previous assessments. Conclusion: All ten patients followed-up 20 – 24 years after an ECT series were mentally healthy and thus besides a moderate visual memory dysfunction no severe side effects were observed with clinical and neuroimaging techniques.
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| 4. |
- Johanson, Per, 1963, et al.
(författare)
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A dynamic model forecasting myocardial infarct size before, during, and after reperfusion therapy: an ASSENT-2 ECG/VCG substudy
- 2005
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Ingår i: Eur Heart J. - : Oxford University Press (OUP). - 0195-668X. ; 26:17, s. 1726-33
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Tidskriftsartikel (refereegranskat)abstract
- AIMS: Serial forecasts of final myocardial infarct (MI) size during fibrinolytic treatment (Rx) of ST-elevation MI would allow the identification of high-risk patients with a predicted major loss of viable myocardium, at a point when treatment may still be modified. We investigated a model for such forecasting, using time and the ECG. METHODS AND RESULTS: We collected 234 patients with ST-elevation MI, without signs of previous MI, bundle branch block, or hypertrophy. MI size was determined by the Selvester score and was "forecasted" at: admission with patients stratified by delay time and an ECG acuteness score into three groups (EARLY, DISCORDANT, and LATE); 90 min after Rx by > or =70% ST-recovery or not and occurrence of "reperfusion peaks"; 4 h after Rx by ST re-elevations. EARLY patients had smaller final infarct sizes than LATE (9.4 vs. 20%, P=0.01). EARLY patients with > or =70% ST-recovery without a reperfusion peak had smaller infarct sizes than those with (3.1 vs. 12.5%, P=0.001). EARLY patients without ST re-elevations had smaller infarct sizes (1.5%) than those with some (9%) or many re-elevations (12%), P<0.001. CONCLUSION: Final infarct size can be forecasted using delay time and serial ECGs. Serially updated forecasts seem especially important when both clock-time and initial ECG- signs indicate earliness.
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| 5. |
- Rebeiz, A. G., et al.
(författare)
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Comparison of ST-segment resolution with combined fibrinolytic and glycoprotein IIb/IIIa inhibitor therapy versus fibrinolytic alone (data from four clinical trials)
- 2005
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Ingår i: Am J Cardiol. - 0002-9149. ; 95:5, s. 611-4
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Tidskriftsartikel (refereegranskat)abstract
- We compared combination fibrinolytic plus glycoprotein IIb/IIIa inhibitor therapy with stand-alone fibrinolysis with respect to speed and stability of reperfusion in patients who had acute ST-segment elevation myocardial infarction; data were obtained from 654 patients in 4 trials (Integrilin to Manage Platelet Aggregation to Combat Thrombosis in Acute Myocardial Infarction, Platelet Aggregation Receptor Antagonist Dose Investigation and Reperfusion Gain in Myocardial Infarction, Integrilin and Tenecteplase in Acute Myocardial Infarction, and the Fifth Global Use of Strategies to Open Occluded Coronary Arteries) that compared thrombolytics plus lamifiban, eptifibatide, or abciximab with standard thrombolysis. We found significantly faster and more stable ST-segment recovery with combination therapy starting at 60 minutes (56.7% vs 48.0% with >/=50% ST-segment resolution, p = 0.03) and sustained over 180 minutes after drug administration; this transient benefit may suggest a time frame when more optimal percutaneous coronary intervention can be performed.
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