Chest PainTRUENCT01836211
High-Sensitivity Troponin T and Coronary Computed Tomography Angiography for Rapid Diagnosis of Emergency Chest Pain
A study testing Fast strategy in people with Chest Pain and Acute Coronary Syndrome, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
The purpose of this study is to determine the efficacy and safety of an evaluation strategy based on utilization of high sensitivity cardiac troponin T (hscTnT), followed by coronary computed tomography angiography (CCTA) in patients with low-intermediate risk chest pain consistent with a possible acute coronary… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chest Pain, Acute Coronary Syndrome
- What is being tested?
- Fast strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2011to Jun 2013
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chest pain consistent with possible acute coronary syndrome.
- Age > 18 years.
- Informed consent.
Who cannot join
- Previous history of coronary artery disease.
- Electrocardiogram diagnostic or suggestive of myocardial ischemia.
- Condition other than coronary artery disease as cause of an imbalance between myocardial oxygen supply and/or demand (eg. anemia, fever, arrhythmias).
- Chronic kidney disease (GFR <30 mL/min/1,73 m2).
- Iodine contrast allergy.
- Incapability to perform treadmill stress test.
- Barthel activity of daily living scale index < 100.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-Sensitivity Troponin T and Coronary Computed Tomography Angiography for Rapid Diagnosis of Emergency Chest Pain: a Randomized Controlled Study
- The purpose of this study is to determine the efficacy and safety of an evaluation strategy based on utilization of high sensitivity cardiac troponin T (hscTnT), followed by coronary computed tomography angiography (CCTA) in patients with low-intermediate risk chest pain consistent with a possible acute coronary syndrome compared to a standard of care (SOC) strategy.
- Unicentric, randomized, controlled, open label clinical trial that will compare a fast strategy (hscTnT followed by CCTA) with a SOC strategy (serial ECG and cardiac biomarkers followed by stress/rest imaging study).
- Conditions
- Chest Pain, Acute Coronary Syndrome
- Being tested
- Fast strategy, Standard of care strategy
- Keywords
- Chest pain, Acute coronary syndrome, Cardiac biomarkers, Computed coronary tomography angiography, Emergency department
- Medical subject headings
- Chest Pain, Acute Coronary Syndrome, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast strategyOther
High sensitivity troponin T followed by computed coronary tomography angiography
Standard of care strategyOther
Standard of care strategy: serial electrocardiograms and cardiac biomarkers followed by stress/rest cardiac imaging study
| Study group | Role | What they receive |
|---|---|---|
| Fast strategy | Experimental | High sensitivity cardiac troponin T followed by computed coronary tomography angiography Receives: Other: Fast strategy |
| Standard of care strategy | Active comparator | Standard of care strategy based on serial electrocardiograms and cardiac biomarkers followed by stress/rest cardiac imaging study Receives: Other: Standard of care strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality, new myocardial infarction, new unstable angina, new heart failure, new hospital admission, new consult to the Emergency Department
Composite end-point.
Measured: 1 month after index event
Secondary outcomes (5)
All cause mortality
Measured: 1 month
Myocardial infarction
Measured: 1 month
Unstable angina
Measured: 1 month
Heart Failure
Measured: 1 month
Hospital admission
New cardiovascular hospital admission
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startSep 2011
- Primary completionApr 2013 (estimated)
- Study completionJun 2013 (estimated)
Why it stopped: low recruitment
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 Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836211
- Sponsor's protocol ID
- IIBSP-DIA-2010-18
- Acronym
- TRUE
- Status last verified
- Apr 2013
- First submitted
- 23 Nov 2012
- Last updated
- 19 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Sensitivity Troponin T and Coronary Computed Tomography Angiography for Rapid Diagnosis of Emergency Chest Pain: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01836211
- Acronym / sponsor ID
- TRUE / IIBSP-DIA-2010-18
- Conditions
- Chest Pain, Acute Coronary Syndrome
- Keywords
- Chest pain, Acute coronary syndrome, Cardiac biomarkers, Computed coronary tomography angiography, Emergency department
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 19 Apr 2013 (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.
- The purpose of this study is to determine the efficacy and safety of an evaluation strategy based on utilization of high sensitivity cardiac troponin T (hscTnT), followed by coronary computed tomography angiography (CCTA) in patients with low-intermediate risk chest pain consistent with a possible acute coronary syndrome compared to a standard of care (SOC) strategy.
- Unicentric, randomized, controlled, open label clinical trial that will compare a fast strategy (hscTnT followed by CCTA) with a SOC strategy (serial ECG and cardiac biomarkers followed by stress/rest imaging study).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast strategy | Experimental | Other: Fast strategyHigh sensitivity cardiac troponin T followed by computed coronary tomography angiography |
| Standard of care strategy | Active comparator | Other: Standard of care strategyStandard of care strategy based on serial electrocardiograms and cardiac biomarkers followed by stress/rest cardiac imaging study |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with chest pain consistent with possible acute coronary syndrome.
- Age > 18 years.
- Informed consent.
Key exclusion criteria (7 listed)
- Previous history of coronary artery disease.
- Electrocardiogram diagnostic or suggestive of myocardial ischemia.
- Condition other than coronary artery disease as cause of an imbalance between myocardial oxygen supply and/or demand (eg. anemia, fever, arrhythmias).
- Chronic kidney disease (GFR <30 mL/min/1,73 m2).
- Iodine contrast allergy.
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 |
|---|---|---|
| Fast strategyHigh sensitivity troponin T followed by computed coronary tomography angiography | Other | Fast strategy |
| Standard of care strategyStandard of care strategy: serial electrocardiograms and cardiac biomarkers followed by stress/rest cardiac imaging study | Other | Standard of care strategy |
Primary outcome
All cause mortality, new myocardial infarction, new unstable angina, new heart failure, new hospital admission, new consult to the Emergency Department
Time frame: 1 month after index event
Composite end-point.
5 secondary outcomes
All cause mortality
Time frame: 1 month
Myocardial infarction
Time frame: 1 month
Unstable angina
Time frame: 1 month
Heart Failure
Time frame: 1 month
Hospital admission
Time frame: 1 month
Results and safety
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2013.
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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 Fast strategy in people with Chest Pain and Acute Coronary Syndrome, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 19 Apr 2013. 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 Spain. 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?
The study was stopped early (reason given: low recruitment). 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?
All cause mortality, new myocardial infarction, new unstable angina, new heart failure, new hospital admission, new consult to the Emergency Department (time frame: 1 month after index event). 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 19 Apr 2013.