Clinical performance of the novel high-sensitivity cardiac troponin I (Siemens-hs-cTnI-Centaur) assay is unknown. We aimed to clinically validate the Siemens-hs-cTnI-Centaur assay and develop 0/1-h ...and 0/2-h algorithms.
We enrolled patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction (AMI). Final diagnoses were centrally adjudicated by 2 independent cardiologists including all clinical information twice: first, using serial hs-cTnT (Roche-Elecsys, primary analysis); second, using hs-cTnI (Abbott-Architect, secondary analysis) measurements in addition to the clinically applied (hs)-cTn. Siemens-hs-cTnI-Centaur was measured at presentation, 1 h, and 2 h. The primary objective was a direct comparison of diagnostic accuracy, quantified by the area under the ROC curve (AUC), of Siemens-hs-cTnI-Centaur vs the 2 established hs-cTn assays (Roche-hs-cTnT-Elecsys, Abbott-hs-cTnI-Architect). Secondary objectives included the development of Siemens-hs-cTnI-Centaur-specific 0/1-h and 0/2-h algorithms.
AMI was the final diagnosis in 318 of 1755 (18%) patients (using Roche-hs-cTnT-Elecsys for adjudication). The AUC at presentation for Siemens-hs-cTnI-Centaur was 0.94 (95% CI, 0.92-0.96) and comparable with 0.95 (95% CI, 0.93-0.97) for Roche-hs-cTnT-Elecsys and 0.93 (95% CI, 0.90-0.96) for Abbott-hs-cTnI-Architect. Applying the derived Siemens-hs-cTnI-Centaur 0/1-h algorithm to the validation cohort, 46% of patients were ruled out (sensitivity, 99.1%; 95% CI, 95.3-100), and 18% of patients were ruled in (specificity, 94.1%; 95% CI, 91.8-95.9). The Siemens-hs-cTnI-Centaur 0/2-h algorithm ruled out 55% of patients (sensitivity, 100%; 95% CI, 94.1-100), and ruled in 18% of patients (specificity, 96.0%; 95% CI, 93.1-97.9). Findings were confirmed in the secondary analyses using serial measurements of Abbott-hs-cTnI-Architect for adjudication.
Diagnostic accuracy and clinical utility of the novel Siemens-hs-cTnI-Centaur assay are high and comparable with the established hs-cTn assays. ClinicalTrials.gov Identifier: NCT00470587.
This article analyses the dynamics of communication, specifically with regard to the significance of visualisations in urban planning between the two competing political regimes of East and West ...Germany in divided Berlin (1945–1989). The article will demonstrate the ways in which planners on either side of the Iron Curtain were confronted with matters unique to their own political contexts and conditions for public communication, as well as how they faced similar challenges in fields of urban renewal and negotiating public participation. The post-war decades in Berlin were marked by strong planning dynamics: large-scale reconstruction after WWII and the ‘showcase character’ of political confrontation and competition. In this context, new strategies of communicating urban planning to the public were developed, such as large-scale development plans, public exhibitions and cross-border media campaigns. Paradigmatic shifts during the mid-1970s generated new discourses about urban renewal and historic preservation. The new focus on small-scale planning in vivid and inhabited inner-city neighbourhoods made new forms of communication and public depiction necessary. In the context of social and political change as well as growing mediatisation, planning authorities utilised aspects of urban identity and civic participation to legitimise planning activities. The article traces two small-scale planning projects for neighbourhoods in East and West Berlin and investigates the interrelation of visual communication instruments in public discourses and planning procedures during the 1980s, a period that prominently featured the new strategy of comprehensive planning. Furthermore, the article highlights the key role of micro-scale changes in the management of urban renewal along both sides of the wall and the emergence of neighbourhood civil engagement and participation.
We aimed to derive and externally validate a 0/2-h algorithm using the high-sensitivity cardiac troponin I (hs-cTnI)-Access assay.
We enrolled patients presenting to the emergency department with ...symptoms suggestive of acute myocardial infarction (AMI) in 2 prospective diagnostic studies using central adjudication. Two independent cardiologists adjudicated the final diagnosis, including all available medical information including cardiac imaging. hs-cTnI-Access concentrations were measured at presentation and after 2 h in a blinded fashion.
AMI was the adjudicated final diagnosis in 164 of 1131 (14.5%) patients in the derivation cohort. Rule-out by the hs-cTnI-Access 0/2-h algorithm was defined as 0-h hs-cTnI-Access concentration <4 ng/L in patients with an onset of chest pain >3 h (direct rule-out) or a 0-h hs-cTnI-Access concentration <5 ng/L and an absolute change within 2 h <5 ng/L in all other patients. Derived thresholds for rule-in were a 0-h hs-cTnI-Access concentration ≥50 ng/L (direct rule-in) or an absolute change within 2 h ≥20 ng/L. In the derivation cohort, these cutoffs ruled out 55% of patients with a negative predictive value (NPV) of 99.8% (95% CI, 99.3-100) and sensitivity of 99.4% (95% CI, 96.5-99.9), and ruled in 30% of patients with a positive predictive value (PPV) of 73% (95% CI, 66.1-79). In the validation cohort, AMI was the adjudicated final diagnosis in 88 of 1280 (6.9%) patients. These cutoffs ruled out 77.9% of patients with an NPV of 99.8% (95% CI, 99.3-100) and sensitivity of 97.7% (95% CI, 92.0-99.7), and ruled in 5.8% of patients with a PPV of 77% (95% CI, 65.8-86) in the validation cohort.
Safety and efficacy of the l hs-cTnI-Access 0/2-h algorithm for triage toward rule-out or rule-in of AMI are very high.
APACE, NCT00470587; ADAPT, ACTRN1261100106994; IMPACT, ACTRN12611000206921.
Jenseits der Utopie? Ajit Jacob Singh; Kathrin Meißner
Suburban,
06/2023, Letnik:
11, Številka:
1/2
Journal Article
Recenzirano
Odprti dostop
Der Beitrag erweitert die bisherigen Untersuchungen von Visualisierungen städtischer Wirklichkeiten um die qualitative Analyse visueller Praktiken und Visualisierungskulturen im Kontext ...stadtplanerischer Beteiligungsverfahren. Am empirischen Fall des Modellprojekts Rathausblock in Berlin-Kreuzberg zeigen wir auf, wie die zu beplanenden Räume und das Verfahren durch die Planungsbeteiligten visualisiert und als umkämpfter und auszuhandelnder Raum sichtbar gemacht werden. Rekonstruiert wird anhand von vier typisch wiederkehrenden Visualisierungsformen (Plänen, Logos, Fotografien und computergestützten Architekturdarstellungen), wie die beteiligten Akteure ihre Positionen, Ziele, Utopien sowie ihr Wissen wirkmächtig und öffentlich kommunizieren. Visualisierungen werden dabei als Produkte sinnhafter menschlicher Imaginationen behandelt, durch die Akteure ihre Welt für sich selbst und für andere versteh- und erfahrbar machen wollen. Im Beitrag wird infolgedessen einerseits die besondere Relevanz der visuellen und symbolischen Konstruktion des Ortes und des Verfahrens durch die beteiligten Akteure herausgearbeitet. Andererseits wird betont, dass die Visualisierungen zumeist die Handlungsprobleme der Beteiligten invisibilisieren und damit eine kritische Analyse auch das zum Gegenstand hat, was nicht gezeigt wird.
Der Beitrag erweitert die bisherigen Untersuchungen von Visualisierungen städtischer Wirklichkeiten um die qualitative Analyse visueller Praktiken und Visualisierungskulturen im Kontext ...stadtplanerischer Beteiligungsverfahren. Am empirischen Fall des Modellprojekts Rathausblock in Berlin-Kreuzberg zeigen wir auf, wie die zu beplanenden Räume und das Verfahren durch die Planungsbeteiligten visualisiert und als umkämpfter und auszuhandelnder Raum sichtbar gemacht werden. Rekonstruiert wird anhand von vier typisch wiederkehrenden Visualisierungsformen (Plänen, Logos, Fotografien und computergestützten Architekturdarstellungen), wie die beteiligten Akteure ihre Positionen, Ziele, Utopien sowie ihr Wissen wirkmächtig und öffentlich kommunizieren. Visualisierungen werden dabei als Produkte sinnhafter menschlicher Imaginationen behandelt, durch die Akteure ihre Welt für sich selbst und für andere versteh- und erfahrbar machen wollen. Im Beitrag wird infolgedessen einerseits die besondere Relevanz der visuellen und symbolischen Konstruktion des Ortes und des Verfahrens durch die beteiligten Akteure herausgearbeitet. Andererseits wird betont, dass die Visualisierungen zumeist die Handlungsprobleme der Beteiligten invisibilisieren und damit eine kritische Analyse auch das zum Gegenstand hat, was nicht gezeigt wird.
Until now, high-sensitivity cardiac troponin (hs-cTn) assays were mainly developed for large central laboratory platforms.
This study aimed to assess the clinical performance of a point-of-care ...(POC)-hs-cTnI assay in patients with suspected myocardial infarction (MI).
This study enrolled patients presenting to the emergency department with symptoms suggestive of MI. Two cardiologists centrally adjudicated the final diagnosis using all clinical data including cardiac imaging. The primary objective was to directly compare diagnostic accuracy of POC-hs-cTnI-TriageTrue versus best-validated central laboratory assays. Secondary objectives included the derivation and validation of a POC-hs-cTnI-TriageTrue–specific 0/1-h algorithm.
MI was the adjudicated final diagnosis in 178 of 1,261 patients (14%). The area under the curve (AUC) for POC-hs-cTnI-TriageTrue at presentation was 0.95 (95% confidence interval CI: 0.93 to 0.96) and was at least comparable to hs-cTnT-Elecsys (AUC: 0.94; 95% CI: 0.93 to 0.96; p = 0.213) and hs-cTnI-Architect (AUC: 0.92; 95% CI: 0.90 to 0.93; p < 0.001). A single cutoff concentration <3 ng/l at presentation identified 45% of patients at low risk with a negative predictive value (NPV) of 100% (95% CI: 99.4% to 100%). A single cutoff concentration >60 ng/l identified patients at high risk with a positive predictive value (PPV) of 76.8% (95% CI: 68.9% to 83.6%). The 0/1-h algorithm ruled out 55% of patients (NPV: 100%; 95% CI: 98.8% to 100%), and ruled in 18% of patients (PPV: 76.8%; 95% CI: 67.2% to 84.7%). Ruled-out patients had cumulative event rates of 0% at 30 days and 1.6% at 2 years. This study confirmed these findings in a secondary analysis including hs-cTnI-Architect for central adjudication.
The POC-hs-cTnI-TriageTrue assay provides high diagnostic accuracy in patients with suspected MI with a clinical performance that is at least comparable to that of best-validated central laboratory assays. (Advantageous Predictors of Acute Coronary Syndromes Evaluation Study APACE; NCT00470587)
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Short-term infusions of single vasodilators, usually given in a fixed dose, have not improved outcomes in patients with acute heart failure (AHF).
To evaluate the effect of a strategy that emphasized ...early intensive and sustained vasodilation using individualized up-titrated doses of established vasodilators in patients with AHF.
Randomized, open-label blinded-end-point trial enrolling 788 patients hospitalized for AHF with dyspnea, increased plasma concentrations of natriuretic peptides, systolic blood pressure of at least 100 mm Hg, and plan for treatment in a general ward in 10 tertiary and secondary hospitals in Switzerland, Bulgaria, Germany, Brazil, and Spain. Enrollment began in December 2007 and follow-up was completed in February 2019.
Patients were randomized 1:1 to a strategy of early intensive and sustained vasodilation throughout the hospitalization (n = 386) or usual care (n = 402). Early intensive and sustained vasodilation was a comprehensive pragmatic approach of maximal and sustained vasodilation combining individualized doses of sublingual and transdermal nitrates, low-dose oral hydralazine for 48 hours, and rapid up-titration of angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or sacubitril-valsartan.
The primary end point was a composite of all-cause mortality or rehospitalization for AHF at 180 days.
Among 788 patients randomized, 781 (99.1%; median age, 78 years; 36.9% women) completed the trial and were eligible for primary end point analysis. Follow-up at 180 days was completed for 779 patients (99.7%). The primary end point, a composite of all-cause mortality or rehospitalization for AHF at 180 days, occurred in 117 patients (30.6%) in the intervention group (including 55 deaths 14.4%) and in 111 patients (27.8%) in the usual care group (including 61 deaths 15.3%) (absolute difference for the primary end point, 2.8% 95% CI, -3.7% to 9.3%; adjusted hazard ratio, 1.07 95% CI, 0.83-1.39; P = .59). The most common clinically significant adverse events with early intensive and sustained vasodilation vs usual care were hypokalemia (23% vs 25%), worsening renal function (21% vs 20%), headache (26% vs 10%), dizziness (15% vs 10%), and hypotension (8% vs 2%).
Among patients with AHF, a strategy of early intensive and sustained vasodilation, compared with usual care, did not significantly improve a composite outcome of all-cause mortality and AHF rehospitalization at 180 days.
ClinicalTrials.gov Identifier: NCT00512759.
The aim of this study was to validate the clinical performance of the Beckman Access high-sensitivity cardiac troponin I (hs-cTnI) assay.
We enrolled patients presenting to the emergency department ...with symptoms suggestive of acute myocardial infarction (AMI). Final diagnoses were centrally adjudicated by 2 independent cardiologists with all clinical information including cardiac imaging twice: first, using serial hs-cTnT (Elecsys, primary analysis), and second, using hs-cTnI (Architect, secondary analysis) measurements in addition to the clinically used hs-cTn. hs-cTnI Access was measured at presentation and at 1 h. The primary objective was a direct comparison of diagnostic accuracy as quantified by the area under the ROC curve (AUC) of hs-cTnI Access vs the hs-cTnT Elecsys and hs-cTnI Architect assays. Secondary objectives included the derivation and validation of an hs-cTnI Access-specific 0/1-h algorithm.
AMI was the adjudicated final diagnosis in 243 of 1579 (15.4%) patients. The AUC at presentation for hs-cTnI Access was 0.95 (95% CI, 0.94-0.96), higher than hs-cTnI Architect 0.92 (95% CI, 0.91-0.94;
< 0.001) and comparable to hs-cTnT Elecsys 0.94 (95% CI, 0.93-0.95;
= 0.12). Applying the derived hs-cTnI Access 0/1-h algorithm (derivation cohort n = 686) to the validation cohort (n = 680), 60% of patients were ruled out sensitivity, 98.9% (95% CI, 94.3-99.8), and 15% of patients were ruled in specificity, 95.9% (95% CI, 94.0-97.2). Patients ruled out by the 0/1-h algorithm had a survival rate of 100% at 30 days. Findings were confirmed in the secondary analyses by the adjudication including serial measurements of Architect hs-cTnI.
Diagnostic accuracy and clinical utility of the Beckman hs-cTnI Access assay are very high and at least comparable to Roche hs-cTnT and Abbott hs-cTnI assays.
NCT00470587.
Abstract
Aims
We aimed to evaluate the impact of age on the performance of the European Society of Cardiology (ESC) 0/1h-algorithms and to derive and externally validate alternative cut-offs specific ...to older patients.
Methods and results
We prospectively enrolled patients presenting to the emergency department (ED) with symptoms suggestive of acute myocardial infarction in three large diagnostic studies. Final diagnoses were adjudicated by two independent cardiologists. High-sensitivity cardiac troponin (hs-cTn) T and I concentrations were measured at presentation and after 1 h. Patients were stratified according to age <55 years (young), ≥55 to <70 years (middle-age), ≥70 years (old). Rule-out safety of the ESC hs-cTnT 0/1h-algorithm was very high in all age-strata: sensitivity 100% 95% confidence interval (95% CI) 94.9–100 in young, 99.3% (95% CI 96.0–99.9) in middle-age, and 99.3% (95% CI 97.5–99.8) in old patients. Accuracy of rule-in decreased with age: specificity 97.0% (95% CI 95.8–97.9) in young, 96.1% (95% CI 94.5–97.2) in middle-age, and 92.7% (95% CI 90.7–94.3) in older patients. Triage efficacy decreased with increasing age (young 93%, middle-age 80%, old 55%, P < 0.001). Similar results were found for the ESC hs-cTnT 0/1h-algorithm. Alternative, slightly higher cut-off concentrations optimized for older patients maintained very high safety of rule-out, increased specificity of rule-in (P < 0.01), reduced overall efficacy for hs-cTnT (P < 0.01), while maintaining efficacy for hs-cTnI. Findings were confirmed in two validation cohorts (n = 2767).
Conclusion
While safety of the ESC 0/1h-algorithms remained very high, increasing age significantly reduced overall efficacy and the accuracy of rule-in. Alternative slightly higher cut-off concentrations may be considered for older patients, particularly if using hs-cTnI.
Clinical Trial Registration
https://clinicaltrials.gov/ct2/show/NCT00470587, number NCT00470587 and NCT02355457 (BACC).
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