The utility of presentation and 4-hour high sensitivity troponin I to rule-out acute myocardial infarction in the emergency department.
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):1219-24. doi: 10.1016/j.clinbiochem.. Epub
2015 Jul 29.The utility of presentation and 4-hour high sensitivity troponin I to rule-out acute myocardial infarction in the emergency department.1, 2, 3, 4, 5, 5, 6, 7, 1, 6, 8.1Emergency Department, Christchurch Hospital, Christchurch, New Z University of Otago, Christchurch, New Zealand.2Lipid and Diabetes Research Group, Christchurch, New Zealand.3Canterbury Health Laboratories, Christchurch, New Z University of Otago, Christchurch, New Zealand.4Cardiology Department, Christchurch Hospital, Christchurch, New Zealand.5Department of Emergency Medicine, Royal Brisbane and Women's Hospital, Brisbane, A School of Medicine, The University of Queensland, Brisbane, A School of Public Health, The Queensland University of Technology, Brisbane, Australia.6University of Otago, Christchurch, New Zealand.7University of Otago, Christchurch, New Z Cardiology Department, Christchurch Hospital, Christchurch, New Zealand.8Emergency Department, Christchurch Hospital, Christchurch, New Zealand. Electronic address: martin.than@xtra.co.nz.AbstractOBJECTIVES: International guidance recommends that early serial sampling of high sensitivity troponin be used to accurately identify acute myocardial infarction (AMI) in chest pain patients. The background evidence for this approach is limited. We evaluated whether on presentation and 4-hour high-sensitivity troponin I (hs-cTnI) could be used to accurately rule-out AMI.DESIGN AND METHODS: hs-cTnI was measured on presentation and at 4-hours in adult patients attending an emergency department with possible acute coronary syndrome. We determined the sensitivity for AMI for at least one hs-cTnI above the 99th percentile for a healthy population or alone or in combination with new ischemic ECG changes. Both overall and sex-specific 99th percentiles were assessed. Patients with negative tests were designated low-risk.RESULTS: 63 (17.1%) of 368 patients had AMI. The median (interquartile range) time from symptom onset to first blood sampling was 4.8h (2.8-8.6). The sensitivity of the presentation and 4h hs-cTnI using the overall 99th percentile was 92.1% (95% CI 82.4% to 97.4%) and negative predictive value 95.4% (92.3% to 97.4%) with 78.3% low-risk. Applying the sex-specific 99th percentile did not change the sensitivity. The addition of ECG did not change the sensitivity.CONCLUSION: Hs-cTnI &99th percentile thresholds measured on presentation and at 4-hours was not a safe strategy to rule-out AMI in this clinical setting irrespective of whether sex-specific 99th percentiles were used, or whether hs-cTnI was combined with ECG results.Copyright (C) 2015 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.KEYWORDS: Accelerate Acu Acute m E E High
NSTEMI; StemiPMID:
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External link. Please review our .Short-term (90 min) diagnostic performance for acute non-ST segment elevation myocardial infarction and 30-day prognostic evaluation of a novel thi...
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-17):. doi: 10.1016/j.clinbiochem.. Epub
2012 Jun 15.Short-term (90 min) diagnostic performance for acute non-ST segment elevation myocardial infarction and 30-day prognostic evaluation of a novel third-generation high sensitivity troponin I assay.1, , .1Division of Emergency Medicine, Stanford University School of Medicine, Stanford, CA , United States. donalds@stanford.eduAbstractOBJECTIVES: We evaluated a third-generation high sensitivity "guidelines acceptable" troponin I assay (hs-cTnI) against a contemporary "clinically usable" troponin assay (cTnI).DESIGN AND METHODS: Remnant samples of undifferentiated emergency department (ED) patients with suspected acute coronary syndrome were enrolled. Baseline and 90-minute samples were analyzed for cTnI and hs-cTnI. Sensitivity, specificity, positive and negative predictive values for AMI and 30-day adverse cardiac events (ACE) were compared.RESULTS: Of 486 ED patients, there were 465 patients who had blood remaining at the presentation for the hs-cTnI assays, with 12 AMIs. At presentation, the clinical sensitivity and specificity for AMI was 75% and 97% for cTnI and 83.3 and 82.1% for hs-cTnI. There were 407 patients who had paired baseline and 90-minute blood samples for cTnI and hs-cTnI including 9 of the 12 AMI patients. The sensitivity and specificity was 77.7% and 96.5% for cTnI and 100% and 81.9% for hs-cTnI at 90 min. A Δ change of 30% increase from baseline to 90 min improved the specificity to 94.5% (95% CI 92%-96%) without lowering the sensitivity. When AMI was defined as a Δ30% change of hs-cTnI at t=0 and 90 min and one hs-cTnI result &99th percentile cutoff, more than 3 times as many patients met the diagnostic criteria for AMI compared to results from the normal sens 28 (6.9%) for hs-cTnI vs. 9 (2.2%) with cTnI. There were 37 in-hospital or 30-day events, producing an OR of 3.03, 95% CI: 0.86-9.59 for cTnI, and 2.54, 95% CI: 1.27-5.10 for hs-cTnI, which detected 11 more cases.CONCLUSIONS: The hs-cTnI assay achieved a 90-minute rule out for AMI and detected more 3 times as many AMI cases. The specificity increased with the Δ30% criteria. The hs-cTnI assay also detected more cases of patient at risk for adverse cardiac events at 30 days.Copyright (C) 2012 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.PMID:
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Official Title: “A Multicenter, Randomized, Double-blind, Crossover Placebo-controlled Phase II Study to Assess the Effect of Serelaxin Versus Placebo on High-sensitivity Cardiac Troponin I (Hs-cTnI) Release in Patients With Chronic Heart Failure After Exercise When Used in Addition to Standard of Care”
This is a multicenter, randomized, double-blind, crossover, placebo-controlled, Phase II clinical study to evaluate the effect of serelaxin versus placebo (both in addition to SoC) on the release of hs-cTnI, in patients with CHF after an exercise testing session.
Study Type: InterventionalStudy Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: TreatmentStudy Primary Completion Date: May 2017
Interventions Used in this Clinical Trial
Drug: SerelaxinSerelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimenDrug: PlaceboMatching placebo i.v infusion
Arms, Groups and Cohorts in this Clinical Trial
Experimental: Serelaxin followed by PlaceboOn Day 1 of treatment period 1, Serelaxin will be administered as a continuous i.v.infusion according to a weight-range adjusted dosing regimen The routine exercise assessment will commence at minute 120. In treatment period 2, on day 15 ± 1, matching placebo will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen.Experimental: Placebo followed by SerelaxinOn Day 1 of treatment period 1, matching placebo will be administered as a continuous i.v.infusion according to a weight-range adjusted dosing regimen The routine exercise assessment will commence at minute 120. In treatment period 2, on day 15 ± 1, Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen.
Outcome Measures for this Clinical Trial
Primary MeasuresHigh sensitivity cardiac troponin I (hs-cTnI) concentration after exercise compared to placeboTime Frame: Baseline, up to 5 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15+/- 1)Safety Issue?: NoSecondary MeasuresHigh sensitivity cardiac troponin I (hs-cTnI) concentrations after exercise compared to placeboTime Frame: 4 and 5 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15 +/-1)Safety Issue?: NoN-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations compared to placeboTime Frame: Baseline, up to 5 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15 +/- 1)Safety Issue?: NoHeart-type fatty acid-binding protein (H-FABP) concentrations compared to placeboTime Frame: Baseline, up to 5 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15 +/- 1)Safety Issue?: NoNumber of patients reported with total adverse events and serious adverse eventsTime Frame: From signature of consent until 30 days after last study visit (maximum 75 days)Safety Issue?: Yes
Criteria for Participation in this Clinical Trial
Key Inclusion Criteria:Male or female ≥ 18 years of age, with body weight ≤ 160 Kg
Diagnosis of stable CHF:New York Heart Association (NYHA) functional Class II/III. Receiving guideline-recommended treatment for CHF.Left ventricular ejection fraction & 45%, obtained within the last 3 months prior to screening.
NT-proBNP & 300 ng/L in sinus rhythm or & 900 ng/L if not in sinus rhythm (determined locally).
Ability to exercise for at least 10 to 12 minutes based on investigator's judgment.
Systolic BP ≥ 125 mm Hg at randomization
Renal function defined as an eGFR of ≥ 25 mL/min/1.73 m^2 at screening (sMDRD formula).Key Exclusion Criteria:Dyspnea primarily due to non-cardiac causes.
Increased risk of developing hypotension during vasodilator therapy according to investigators judgement.
Any contraindication for exercise testing and spirometry.
Stopping of the spiroergometry at screening according to the stopping rules, unless the patient has reached maximum exercise capacity defined as carbon dioxide production/oxygen consumption (VCO2/VO2) & 1.05.
Change in guideline-recommended CHF treatment within 1 month prior to screening.
Gender Eligibility for this Clinical Trial: BothMinimum Age for this Clinical Trial: 18 YearsMaximum Age for this Clinical Trial: N/AAre Healthy Volunteers Accepted for this Clinical Trial: No
Clinical Trial Investigator Information
Lead SponsorNovartis PharmaceuticalsProvider of Information About this Clinical Study
SponsorOverall Official(s)Novartis Pharmaceuticals, Study Director, Novartis PharmaceuticalsOverall Contact(s)Novartis Pharmaceuticals, +
Additional Information on this Clinical Trial
ClinicalTrials.gov processed this data on August 08, 2016Link to the current ClinicalTrials.gov record. – https://clinicaltrials.gov/show/NCTStudy ID Number: CRLX030A2211ClinicalTrials.gov Identifier: NCTHealth Authority: Germany: Federal Institute for Drugs and Medical Devices (BfArM)
Clinical Trials content is provided directly by the US National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of information about a specific clinical trial contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
Conditions in this Clinical Trial
Additional Key Areas Provided by Clinical Trial Investigators
Interventions in this Clinical Trial
Condition MeSH Term(s), Assigned with an Experimental Algorithm
About Clinical Trials Research
Site Details超敏肌钙蛋白I水平高低与不稳定型心绞痛患者冠状动脉病变严重程度相关性研究(R)网聚医学的力量，源自中国医学论坛报
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超敏肌钙蛋白I水平高低与不稳定型心绞痛患者冠状动脉病变严重程度相关性研究
&&&&&&&&&　　近期，武汉大学人民医院心内科研究人员发表论文，旨在探讨不同血清水平的超敏肌钙蛋白与不稳定型心绞痛患者冠状动脉病变情况的相关性。研究指出，超敏肌钙蛋白是预测心肌损伤的独立标志物。对于传统肌钙蛋白阴性的患者，可以用超敏肌钙蛋白来预测患者冠状动脉病变情况，进行危险分层。该文发表在2014年第12期《医学研究杂志》上。 　　纳入91例传统肌钙蛋白I（cardiactroponinI，cTnI）阴性的
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　　近期，武汉大学人民医院心内科研究人员发表论文，旨在探讨不同血清水平的与患者冠状动脉病变情况的相关性。研究指出，超敏肌钙蛋白是预测心肌损伤的独立标志物。对于的患者，可以用超敏肌钙蛋白来预测患者冠状动脉病变情况，进行危险分层。该文发表在2014年第12期《医学研究杂志》上。
　　纳入91例传统肌钙蛋白I（cardiac&troponin&I，cTnI）阴性的患者，住院后第2天清晨空腹抽血检查超敏肌钙蛋白I（high-sensitivity&cardiac&troponin&I，hs-cTnI），根据超敏肌钙蛋白检测值将患者分为3组：A组为hs-cTnI&0.005ng/ml，B组为0.005ng/ml&hs-cTnI&0.01ng/ml，C组为hs-cTnI&0.01ng/ml。根据患者住院期间结果，记录患者冠状动脉狭窄程度及病变支数。
　　随着超敏肌钙蛋白水平的升高，患者冠状动脉狭窄程度逐渐加重（P&0.05），且冠脉病变支数增多（P&0.05）。
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