Chest PainCONECTTINNCT02772991
Analysis Between Coronary Angiotomography and Sensitive Troponin in Intermediate Risk of Acute Coronary Syndrome
A study testing troponin measurement in people with Chest Pain and Acute Coronary Syndrome, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Chest Pain, Acute Coronary Syndrome
- What is being tested?
- troponin measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Chest Pain, Acute Coronary Syndrome
- Being tested
- troponin measurement
- Medical subject headings
- Chest Pain, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
troponin measurementOther
Also called coronary CT angiopraphy
Cardiac catheterization (for patients with >50% lesions) or discharge or in patients with intermediate risk.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Experimental | 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. Receives: Other: troponin measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events according to phone contact after 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.
Measured: 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.
ROC curve / ANOVA
Measured: 30 days
Secondary outcomes (1)
Stablish the cut off for troponin levels
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.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2017
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772991
- Sponsor's protocol ID
- PSInCor-TropoUS
- Acronym
- CONECTTIN
- Status last verified
- Jan 2017
- First submitted
- 26 Apr 2016
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02772991
- Acronym / sponsor ID
- CONECTTIN / PSInCor-TropoUS
- Conditions
- Chest Pain, Acute Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2018 (estimated)
- First posted
- 16 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases | Experimental | Other: troponin measurementAll 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. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| troponin measurementAlso: coronary CT angiopraphyCardiac catheterization (for patients with >50% lesions) or discharge or in patients with intermediate risk. | Other | Cases |
Primary outcome
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
1 secondary outcome
Stablish the cut off for troponin levels
Time frame: 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing troponin measurement in people with Chest Pain and Acute Coronary Syndrome, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events according to phone contact after 30 days (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.