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临床试验/NCT02772991
NCT02772991Unknown不适用

COmparative Prospective aNalysis betweEn Coronary angioTomography and Sensitive Troponin in Patients With Chest Pain and INtermediate Risk of Acute Coronary Syndrome in the Emergency Room - CONECTTIN Trial

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Compare the sensitivity, specificity, and negative and positive predictive values between the high sensitivity troponin and the CCTA in the detection of an ACS.

研究概览

简要总结

In recent years, a large number of studies have been conducted on how to improve the treatment of patients in the Emergency Room (ER) complaining of chest pains. Great advances have been achieved recently regarding diagnostic methods aided by coronary CT angiopraphy (CCTA) and sensitive troponins. However, various questions about these methods still remain obscure and there is no effective comparison between them in patients with intermediate risk. The aim of the study is to evaluate the sensitivity and specificity of sensitivity troponins in the detection of coronary artery disease in patients with chest pain and the intermediate probability of ACS compared with CCTA.

详细描述

This will be a prospective and unicentric study with approximately 200 subjects recruited over a planned recruitment period of 24 months. Based on an alpha error of 0.05 and using a power of 0.8 for the primary outcomes, investigators calculated the number of individuals necessary for the study to be at least 141. All patients will be submmited to troponin measurements and CCTA. The commercial kit ADVIA Centaur® TnI-Ultra (Siemens Healthcare Diagnostics, Tarrytown, NY, USA) is used for this in automated equipment of the same brand. It is measured at the central InCor laboratory. The 99th percentile value is 0.04 ng/ml. The CCTA used will be the 320-channel Toshiba Aquilium machine. If the CCTA result shows coronary stenosis greater than or equal to 50%, the patient will initiate the ACS treatment and be hospitalized to have coronary cineangiography. In case the CCTA shows lesions of less than 50%, the patient will be discharged and monitored for 30 days by telephone. This conduct is already followed as a routine in the emergency unit at InCor for both situations. A second sampling of the troponin kit will be obtained from all patients three hours after the first collection in order to evaluate for an increase/decrease of troponin. This second troponin measurement, however, it is blinded to the main investigator, who will only have access to it after the evaluation of outcomes at the end of the study. All the data will be placed in a Microsoft Access database table and analyzed with the SAS Statview 5.0 software. The comparative analysis between the methods will be made using the area under the ROC curve and obtaining sensitivity, specificity, positive and negative predictive values, and accuracy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • chest pain for at least two hours before arriving at the emergency unit
  • non-diagnostic electrocardiogram (absence of new or probable deviation of ST of at least 0.5 mV and/or T wave inversion of at least 0.2 mV)
  • TIMI risk of 3 or 4
  • first measurement of troponin I less than or equal to ≤ 0.03 ng/ml
  • informed consent form signed.

排除标准

  • pregnancy
  • hemodynamic instability (pulmonary congestion / systolic arterial pressure lower than 90 mmHg)
  • serum creatinine higher than 1.5 mg/dL
  • intolerance to ß-blockers
  • allergy to iodinated contrast
  • thoracic trauma within the last 30 days
  • body mass index greater than 40 kg/ m2
  • previous surgical myocardial revascularization
  • other identified causes of troponin increase

结局指标

主要结局

Compare the sensitivity, specificity, and negative and positive predictive values between the high sensitivity troponin and the CCTA in the detection of an ACS.

时间窗: 30 days

ROC curve / ANOVA

Number of participants with adverse events according to phone contact after 30 days

时间窗: 30 days

Patients whose CCTAs show lesions with stenosis of less than 50%, compare combined outcomes (death, AMI, rehospitalization, and stroke)with the increase/decrease of troponin in the second measurement in 30 days according to phone contact.

次要结局

  • Stablish the cut off for troponin levels(3 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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