Analysis Between Coronary Angiotomography and Sensitive Troponin in Intermediate Risk of Acute Coronary Syndrome (CONECTTIN)
|ClinicalTrials.gov Identifier: NCT02772991|
Recruitment Status : Unknown
Verified January 2017 by University of Sao Paulo General Hospital.
Recruitment status was: Active, not recruiting
First Posted : May 16, 2016
Last Update Posted : February 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chest Pain Acute Coronary Syndrome||Other: troponin measurement||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 2016|
|Actual Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
All patients will be submmited to troponin measurements and CCTA. If CCTA shows coronary stenosis ≥ 50%, patient will initiate the ACS treatment and be hospitalized to have coronary cineangiography. If CCTA shows lesions < 50%, the patient will be discharged and monitored for 30 days. A second sampling of the troponin will be obtained from all patients three hours after the first collection in order to evaluate for an increase/decrease of troponin.
Other: troponin measurement
Cardiac catheterization (for patients with >50% lesions) or discharge or in patients with intermediate risk.
Other Name: coronary CT angiopraphy
- Number of participants with adverse events according to phone contact after 30 days [ Time Frame: 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.
- Compare the sensitivity, specificity, and negative and positive predictive values between the high sensitivity troponin and the CCTA in the detection of an ACS. [ Time Frame: 30 days ]ROC curve / ANOVA
- Stablish the cut off for troponin levels [ Time Frame: 3 hours ]Patients whose CCTAs show coronary lesion with stenosis of more than 50%, compare with lesions with stenosis of more than 70% / acute plaque in the coronary cineangiography. In addition, compare the lesions treated in this group of patients and the increase/decrease of troponin in the second measurement; evaluate the best cut-off point regarding the percentage of variation in the troponin kit between zero and three hours that are related to the presence of lesions with stenosis of more than 70% / acute plaque in the coronary cineangiography.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772991
|Instituto do Coração - HMFMUSP|
|São Paulo, Brazil, 05403000|