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- Filippatos, G. S., et al.
(författare)
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Independent academic Data Monitoring Committees for clinical trials in cardiovascular and cardiometabolic diseases
- 2017
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Ingår i: European Journal of Heart Failure. - : Wiley. - 1388-9842 .- 1879-0844. ; 19:4, s. 449-456
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Tidskriftsartikel (refereegranskat)abstract
- Data Monitoring Committees (DMCs) play a crucial role in the conducting of clinical trials to ensure the safety of study participants and to maintain a trial's scientific integrity. Generally accepted standards exist for DMC composition and operational conduct. However, some relevant issues are not specifically addressed in current guidance documents, resulting in uncertainties regarding optimal approaches for communication between the DMC, steering committee, and sponsors, release of information, and liability protection for DMC members. The Heart Failure Association (HFA) of the European Society of Cardiology (ESC), in collaboration with the Clinical Trials Unit of the European Heart Agency (EHA) of the ESC convened a meeting of international experts in DMCs for cardiovascular and cardiometabolic clinical trials to identify specific issues and develop steps to resolve challenges faced by DMCs.The main recommendations from the meeting relate to methodological consistency, independence, managing conflicts of interest, liability protection, and training of future DMC members. This paper summarizes the key outcomes from this expert meeting, and describes the core set of activities that might be further developed and ultimately implemented by the ESC, HFA, and other interested ESC constituent bodies. The HFA will continue to work with stakeholders in cardiovascular and cardiometabolic clinical research to promote these goals.
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- Foster, J E, et al.
(författare)
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Determination of left ventricular long-axis orientation using MRI: changes during the respiratory and cardiac cycles in normal and diseased subjects
- 2005
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Ingår i: Clinical Physiology and Functional Imaging. - 1475-0961. ; 25:5, s. 286-292
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Tidskriftsartikel (refereegranskat)abstract
- Background: It has previously been shown that magnetic resonance imaging (MRI) can be used to accurately determine left ventricular (LV) long-axis orientation in healthy individuals. However, the inter- and intra-observer variability in patients with acute coronary syndrome (ACS) and chronic heart failure (CHF) has not been explored. Furthermore, the changes in LV long-axis orientation because of respiration and during the cardiac cycle remain to be determined. Methods: LV long-axis orientation was determined by MRI in the frontal and transverse planes in 44 subjects with no cardiac disease, 20 ACS patients and 13 CHF patients. Changes in LV long-axis orientation because of respiration were assessed in a subset of 25 subjects. Changes during the cardiac cycle were assessed in six subjects from each subject group. Reproducibility was assessed by a re-examination of 17 subjects after 28 days. Results: The inter- and intra-observer variability for LV long-axis orientation was low for all subject groups. The difference between the baseline and the 28 days examinations was -1.4 +/- 5.9 degrees and -0.8 +/- 4.4 degrees in the frontal and transverse planes, respectively. No significant change in LV long-axis orientation was found between end-expiration and end-inspiration (frontal plane, P = 0.63 and transverse plane, P = 0.42; n = 25). No significant difference in change of the LV long-axis orientation during the cardiac cycle was found between the subject groups (frontal plane, chi-square 1.8, P = 0.40 and transverse plane, chi-square 5.7, P = 0.06). Conclusions: There is a low inter-and intra-observer variability and a high reproducibility for determining LV long-axis orientation in patients with no cardiac disease as well as in patients with ACS or CHF. There is no significant change in LV long-axis orientation due to respiration, and only small changes during the cardiac cycle in these groups.
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- Martin, Thomas N., et al.
(författare)
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ST-Segment deviation analysis of the admission 12-lead electrocardiogram as an aid to early diagnosis of acute myocardial infarction with a cardiac magnetic resonance imaging gold standard
- 2007
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Ingår i: Journal of the American College of Cardiology. - : Elsevier BV. - 0735-1097. ; 50:11, s. 1021-1028
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Tidskriftsartikel (refereegranskat)abstract
- Objectives The purpose of this study was to validate existing 12-lead electrocardiographic (ECG) ST-segment elevation myocardial infarction (STEMI) criteria in the diagnosis of acute myocardial infarction (AMI) and the application of similar ST-segment depression (STEM I-equivalent) criteria with contrast-enhanced cardiac magnetic resonance imaging (ceMRI) as the diagnostic gold standard. Background The admission ECG is the cornerstone in the diagnosis of AMI, and ceMRI is a new diagnostic gold standard that can be used to validate existing and novel 12-lead ECG criteria. Methods One hundred fifty-one consecutive patients with their first hospital admission for chest pain underwent ceMRI. The 116 patients without ECG confounding factors were included in this study, and AMI was confirmed in 58 (50%). The admission ECG was evaluated on the basis of the lead distribution of ST-segment deviation according to current American College of Cardiology/European Society of Cardiology (ACC/ESC) guidelines. Results A sensitivity of 50% and specificity of 97% for AMI were achieved with the currently applied ST-segment elevation criteria. Consideration of ST-segment depression in addition to elevation increased sensitivity for detection of AMI from 50% to 84% (p < 0.0001) but only decreased specificity from 97% to 93% (p = 0.50). There were no significant differences in AMI location or size between patients meeting the 12-lead ACC/ESC ST-segment elevation criteria and those only meeting the ST-segment depression criteria. Conclusions In patients admitted to hospital with possible AMI, the consideration of both ST-segment elevation and depression in the standard 12 lead-ECG recording significantly increases the sensitivity for the detection of AMI with only a slight decrease in the specificity.
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