Acute Coronary SyndromeNCT01682096
Pilot Safety Study of Coronary CTA for the Diagnosis of Acute Coronary Syndrome in the Emergency Room
A study testing computed coronary angiography and Exercise stress echocardiography in people with Acute Coronary Syndrome and Coronary Artery Disease, run by José Ortiz at 1 site in Spain.
Trial summary
The Diagnosis of acute coronary syndrome in patients presenting with acute chest pain is problematic when both, electrocardiogram and serum troponins are normal. Multidetector row computed tomography angiography (CTA) allows direct and rapid non-invasive visualization of coronary artery disease. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Coronary Artery Disease, Cardiac Death
- What is being tested?
- computed coronary angiography and Exercise stress echocardiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2010to Oct 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is in Sinus Rhythm
- Typical or atypical chest pain lasting more than 5 min in the last 24 hs.
- Estimated pre-test probability of significant coronary artery disease more than 15%.
- Absence of ECG changes suggestive of myocardial ischemia (ST-segment deviation >1 mm or T Wave inversion > 4 mm in at least two contiguous leads).
- Negative initial troponins I at admission (<0.05 ng/ml)
Who cannot join
- Known allergy to iodinated contrast.
- Known renal insufficiency or Creatinine >1.5 mg/dl at admission.
- History of known coronary artery disease or prior myocardial revascularization
- Any of the following:hemodynamic instability, persistent chest pain despite treatment, Systolic blood pressure <100 mm Hg.
- Cardiac arrhythmia with rapid or irregular ventricular response.
- Inability to perform an exercise test.
- Patient is incapable of providing informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usefulness of Coronary CTA for the Diagnosis of Acute Coronary Syndrome in the Emergency Room.
The Diagnosis of acute coronary syndrome in patients presenting with acute chest pain is problematic when both, electrocardiogram and serum troponins are normal. Multidetector row computed tomography angiography (CTA) allows direct and rapid non-invasive visualization of coronary artery disease.
The investigator's aim is to assess the diagnostic accuracy and safety of a novel diagnostic strategy based on MDCT as compared to a strategy using stress echocardiography in the workup of patient with chest pain, normal electrocardiogram, normal troponins and suspected coronary artery disease. Additionally, the cost associated with both strategies will be compared.
Methods. A total of 150 patients with acute chest pain coming to the emergency room with intermediate probability of significant coronary artery disease, normal ECG and troponins will be prospectively randomized to MDCT or stress echocardiography with exercise. Patients showing coronary stenosis >50% at MDCT or abnormal stress echocardiography or inconclusive results will be admitted for further study. The primary endpoint of the study is the detection of an acute coronary syndrome, defined as typical or atypical angina with documented significant coronary artery disease (>50% stenosis) on invasive coronariography, a positive stress test or the occurrence of cardiac death, myocardial infarction or need for revascularization during 6 month follow-up. All MDCT angiograms and echocardiograms will be evaluated by an experienced radiologist and cardiologist.
Read the detailed description
Design and Aim: This is a prospective pilot study to evaluate the role of multidetector row computed tomography angiography (CTA) to rule out Acute Coronary Syndrome among patients presenting to the ER with chest pain complaints, non-diagnostic ECG and normal troponins and intermediate pre-test probability for significant CAD.
Methods: Following the initial clinical evaluation and the results of initial ECG, blood test and X-ray, patients meeting the inclusion criteria will be randomized to undergo either a CTA scan or a Exercise Stress Echocardiogram to rule out significant coronary artery disease.
CTA will be carried out in a 64 or 128 slice-CT Scanner (SIEMENS,Somaton Sensation 64 or 128-Flash Definition)following iv administration of iodinated contrast (bolus: 5cc x acquisition time (seg)+ 10 cc). Images will be interpreted by two experienced physicians (radiologist and cardiologist)
Stress Echocardiography will be performed and interpreted by an experienced Echocardiographer (cardiologist).
Clinical decision making: Patients with a positive or inconclusive test in each arm will be admitted to the hospital for treatment or further additional testing, while patients with negative results will be discharged from the ER.
Safety issues: A phone call and chart review will be performed one month and 6 months follow-up to register the occurrence of any major adverse cardiac events, as well as new consultation for chest pain.
- Being tested
- computed coronary angiography, Exercise stress echocardiography
- Keywords
- Chest pain, Emergency room, Acute coronary syndrome, Computed tomography coronary angiography, Stress echocardiography
- Medical subject headings
- Acute Coronary Syndrome, Coronary Artery Disease, Death, Myocardial Infarction, Chest Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computed coronary angiographyRadiation
Also called coronary cta, SIEMENS 64/128 slice CT scanner
Patients will be pre-medicated with atenolol 50 mg 1h prior to the scan.
Exercise stress echocardiographyProcedure or surgery
Also called Treadmil exercise stress echocardiography
Limited by symptoms
| Study group | Role | What they receive |
|---|---|---|
| Computed coronary angiography (CTA) | Active comparator | Patients will undergo a MDCT as the initial diagnostic test to rule out Acute Coronary Syndrome Receives: Radiation: computed coronary angiography |
| Exercise stress echocardiography | Active comparator | Patients will undergo exercise stress echocardiography as the initial diagnostic test to rule out acute coronary syndrome. Receives: Procedure: Exercise stress echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of Acute Coronary Syndrome during admission or occurrence of Major Acute Cardiac Events after discharge
Major adverse cardiac events include: All cause mortality, acute myocardial infarction, need for coronary revascularization
Measured: 6 months
Secondary outcomes (2)
Major adverse cardiac events on follow-up
Safety endpoint: occurrence of MACE among discharged patients in whom acute coronary syndrome has been ruled out according to the test results
Measured: 6 months
Costs during admission (Euros)
The total costs derivated from the admission between the two arms of the study will be compared. Results will be reported in Euros, and will include the costs of the CTA or Stress echocardiography as well as additional tests performed during admission.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startJan 2010
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- José Ortiz
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor-investigator, José Ortiz, Hospital Clinic of Barcelona
- Investigators
- José T Ortiz-Perez, MD, PhD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682096
- Sponsor's protocol ID
- PI09/90513
- Status last verified
- Oct 2013
- First submitted
- 6 Sep 2012
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Coronary CTA for the Diagnosis of Acute Coronary Syndrome in the Emergency Room.
- ClinicalTrials.gov ID
- NCT01682096
- Acronym / sponsor ID
- PI09/90513
- Keywords
- Chest pain, Emergency room, Acute coronary syndrome, Computed tomography coronary angiography, Stress echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- José OrtizUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Jan 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 10 Sep 2012 (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 Diagnosis of acute coronary syndrome in patients presenting with acute chest pain is problematic when both, electrocardiogram and serum troponins are normal. Multidetector row computed tomography angiography (CTA) allows direct and rapid non-invasive visualization of coronary artery disease.
The investigator's aim is to assess the diagnostic accuracy and safety of a novel diagnostic strategy based on MDCT as compared to a strategy using stress echocardiography in the workup of patient with chest pain, normal electrocardiogram, normal troponins and suspected coronary artery disease. Additionally, the cost associated with both strategies will be compared.
Methods. A total of 150 patients with acute chest pain coming to the emergency room with intermediate probability of significant coronary artery disease, normal ECG and troponins will be prospectively randomized to MDCT or stress echocardiography with exercise. Patients showing coronary stenosis >50% at MDCT or abnormal stress echocardiography or inconclusive results will be admitted for further study. The primary endpoint of the study is the detection of an acute coronary syndrome, defined as typical or atypical angina with documented significant coronary artery disease (>50% stenosis) on invasive coronariography, a positive stress test or the occurrence of cardiac death, myocardial infarction or need for revascularization during 6 month follow-up. All MDCT angiograms and echocardiograms will be evaluated by an experienced radiologist and cardiologist.
Detailed description
Design and Aim: This is a prospective pilot study to evaluate the role of multidetector row computed tomography angiography (CTA) to rule out Acute Coronary Syndrome among patients presenting to the ER with chest pain complaints, non-diagnostic ECG and normal troponins and intermediate pre-test probability for significant CAD.
Methods: Following the initial clinical evaluation and the results of initial ECG, blood test and X-ray, patients meeting the inclusion criteria will be randomized to undergo either a CTA scan or a Exercise Stress Echocardiogram to rule out significant coronary artery disease.
CTA will be carried out in a 64 or 128 slice-CT Scanner (SIEMENS,Somaton Sensation 64 or 128-Flash Definition)following iv administration of iodinated contrast (bolus: 5cc x acquisition time (seg)+ 10 cc). Images will be interpreted by two experienced physicians (radiologist and cardiologist)
Stress Echocardiography will be performed and interpreted by an experienced Echocardiographer (cardiologist).
Clinical decision making: Patients with a positive or inconclusive test in each arm will be admitted to the hospital for treatment or further additional testing, while patients with negative results will be discharged from the ER.
Safety issues: A phone call and chart review will be performed one month and 6 months follow-up to register the occurrence of any major adverse cardiac events, as well as new consultation for chest pain.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computed coronary angiography (CTA) | Active comparator | Radiation: computed coronary angiographyPatients will undergo a MDCT as the initial diagnostic test to rule out Acute Coronary Syndrome |
| Exercise stress echocardiography | Active comparator | Procedure: Exercise stress echocardiographyPatients will undergo exercise stress echocardiography as the initial diagnostic test to rule out acute coronary syndrome. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is in Sinus Rhythm
- Typical or atypical chest pain lasting more than 5 min in the last 24 hs.
- Estimated pre-test probability of significant coronary artery disease more than 15%.
- Absence of ECG changes suggestive of myocardial ischemia (ST-segment deviation >1 mm or T Wave inversion > 4 mm in at least two contiguous leads).
- Negative initial troponins I at admission (<0.05 ng/ml)
Key exclusion criteria (7 listed)
- Known allergy to iodinated contrast.
- Known renal insufficiency or Creatinine >1.5 mg/dl at admission.
- History of known coronary artery disease or prior myocardial revascularization
- Any of the following:hemodynamic instability, persistent chest pain despite treatment, Systolic blood pressure <100 mm Hg.
- Cardiac arrhythmia with rapid or irregular ventricular response.
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 |
|---|---|---|
| computed coronary angiographyAlso: coronary cta, SIEMENS 64/128 slice CT scannerPatients will be pre-medicated with atenolol 50 mg 1h prior to the scan. | Radiation | Computed coronary angiography (CTA) |
| Exercise stress echocardiographyAlso: Treadmil exercise stress echocardiographyLimited by symptoms | Procedure or surgery | Exercise stress echocardiography |
Primary outcome
Diagnosis of Acute Coronary Syndrome during admission or occurrence of Major Acute Cardiac Events after discharge
Time frame: 6 months
Major adverse cardiac events include: All cause mortality, acute myocardial infarction, need for coronary revascularization
2 secondary outcomes
Major adverse cardiac events on follow-up
Time frame: 6 months
Costs during admission (Euros)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 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.
José T Ortiz-Perez, MD, PhD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computed coronary angiography and Exercise stress echocardiography in people with Acute Coronary Syndrome and Coronary Artery Disease, run by José Ortiz 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 5 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: finished, as of the sponsor's last update on 16 Oct 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnosis of Acute Coronary Syndrome during admission or occurrence of Major Acute Cardiac Events after discharge (time frame: 6 months). 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 16 Oct 2013.