Analysis Between Coronary Angiotomography and Sensitive Troponin in Intermediate Risk of Acute Coronary Syndrome (CONECTTIN)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772991
|Instituto do Coração - HMFMUSP|
|São Paulo, Brazil, 05403000|