Analysis Between Coronary Angiotomography and Sensitive Troponin in Intermediate Risk of Acute Coronary Syndrome (CONECTTIN)

February 2, 2018 updated by: University of Sao Paulo General Hospital

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

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.

Study Overview

Status

Unknown

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • São Paulo, Brazil, 05403000
        • Instituto do Coração - HMFMUSP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • asthma
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cases
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.
Cardiac catheterization (for patients with >50% lesions) or discharge or in patients with intermediate risk.
Other Names:
  • coronary CT angiopraphy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days
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
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

April 26, 2016

First Submitted That Met QC Criteria

May 13, 2016

First Posted (Estimate)

May 16, 2016

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

February 2, 2018

Last Verified

January 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chest Pain

Clinical Trials on troponin measurement

3
Subscribe