Ignite Creation Date:
2024-05-06 @ 8:35 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02772991
Status:
UNKNOWN
Last Update Posted:
2018-02-05
First Post:
2016-04-26
Brief Title:
Analysis Between Coronary Angiotomography and Sensitive Troponin in Intermediate Risk of Acute Coronary Syndrome
Sponsor:
University of Sao Paulo General Hospital
Organization:
University of Sao Paulo General Hospital
Study Overview
Official Title:
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
Status:
UNKNOWN
Status Verified Date:
2017-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONECTTIN
Brief Summary:
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
Detailed Description:
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 005 and using a power of 08 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 004 ngml 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 increasedecrease 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 50 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None