- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02772991
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
Conditions
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
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-
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São Paulo, Brazil, 05403000
- Instituto do Coração - HMFMUSP
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-
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:
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSInCor-TropoUS
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.
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