Acute Coronary SyndromeNCT00449826
Risk Stratification of Non ST Elevation ACS With Computed Tomographic Angiography (REACT)
A study testing Computed Tomographic Angiography in people with Acute Coronary Syndrome and Non-ST-Elevation Myocardial Infarction, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
The purpose of this project is to examine the effectiveness of computed tomographic angiography (CTA) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS). People who are hospitalized with this situation often require an angiogram to assess the heart and its arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Non-ST-Elevation Myocardial Infarction, Unstable Angina
- What is being tested?
- Computed Tomographic Angiography
- Type of treatment
- Surgery or procedure
- How many people
- 107 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2006to Dec 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High risk ACS
- Angina [accelerating pattern or prolonged episode (> 20 minutes) or recurrent episode at rest or with minimal effort within preceding 24 hours]; and (13)
- Elevated Troponin - T (≥0.1 ug/L) or ECG changes consistent with ischemia [ST depression ≥ 0.1 mV, transient ST segment elevation ≥ 0.1 mV (< 20 minutes)]) (11;13)
- Planned conventional invasive coronary angiography
Who cannot join
- Age < 18 years or lack of consent
- Renal Insufficiency (GFR < 60 ml/min)
- Allergy to contrast agent
- Refractory angina requiring urgent/emergent coronary angiography (as per treating physician)
- Contraindication to radiation exposure (e.g. pregnancy)
- Uncontrolled HR
Show all 9Show fewer
- Previous CABG or PCI/Stent
- Atrial fibrillation, frequent atrial or ventricular ectopy (> 1 / minute)
- Unable to perform 20 second breath-hold
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this project is to examine the effectiveness of computed tomographic angiography (CTA) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS). People who are hospitalized with this situation often require an angiogram to assess the heart and its arteries.
Recent advancements in technology have enabled CTA to clearly define coronary artery anatomy with great accuracy and to guide treatment strategies in select patient populations. We are investigating that CTA may be used, as an alternative to conventional angiograms, for the risk stratification of patients with high risk NSTE-ACS.
Patients eligible for the study will be high risk NSTE-ACS and awaiting an angiogram. Enrolled patients will undergo CTA prior to the angiogram. With each CTA the patient will be injected with a small dose of an X-ray dye and will be asked to lie still on the "scanning bed" for a period of 5-10 minutes.
- Being tested
- Computed Tomographic Angiography
- Keywords
- ACS, Unstable Angina, NSTEMI
- Medical subject headings
- Acute Coronary Syndrome, Non-ST Elevated Myocardial Infarction, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed Tomographic AngiographyProcedure or surgery
CT scan
What is being measured
The primary outcome is the main question the study is designed to answer.
Operating Characteristics of CTA
Measured: 1 month
Secondary outcomes (2)
To compare the accuracy of CTA to CICA in predicting the mode of revascularization (PCI versus CABG) in NSTE-ACS patients.
Measured: 1 month
To determine the number of "avoidable" CICA (i.e. those accurately designated to medical therapy or surgery with CTA).
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 posted21 Mar 2007 (estimated)
- Study startSep 2006
- Primary completionDec 2008
- Study completionDec 2010
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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Chow, Ottawa Heart Institute Research Corporation
- Investigators
- Carole Dennie, MD, Study director, The Ottawa HospitalDerek So, MD, Study director, Ottawa Heart Institute Research CorporationChris Glvoer, MD, Study director, Univeristy of Ottawa Heart InstituteBenjamin JW Chow, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449826
- Sponsor's protocol ID
- UOHI 2006361-01H
- Status last verified
- Jan 2012
- First submitted
- 20 Mar 2007
- Last updated
- 26 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Stratification of Non ST Elevation ACS With Computed Tomographic Angiography (REACT)
- ClinicalTrials.gov ID
- NCT00449826
- Acronym / sponsor ID
- UOHI 2006361-01H
- Keywords
- ACS, Unstable Angina, NSTEMI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 21 Mar 2007 (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 project is to examine the effectiveness of computed tomographic angiography (CTA) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS). People who are hospitalized with this situation often require an angiogram to assess the heart and its arteries.
Recent advancements in technology have enabled CTA to clearly define coronary artery anatomy with great accuracy and to guide treatment strategies in select patient populations. We are investigating that CTA may be used, as an alternative to conventional angiograms, for the risk stratification of patients with high risk NSTE-ACS.
Patients eligible for the study will be high risk NSTE-ACS and awaiting an angiogram. Enrolled patients will undergo CTA prior to the angiogram. With each CTA the patient will be injected with a small dose of an X-ray dye and will be asked to lie still on the "scanning bed" for a period of 5-10 minutes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- High risk ACS
- Planned conventional invasive coronary angiography
Key exclusion criteria (9 listed)
- Age < 18 years or lack of consent
- Renal Insufficiency (GFR < 60 ml/min)
- Allergy to contrast agent
- Refractory angina requiring urgent/emergent coronary angiography (as per treating physician)
- Contraindication to radiation exposure (e.g. pregnancy)
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 Tomographic AngiographyCT scan | Procedure or surgery | – |
Primary outcome
Operating Characteristics of CTA
Time frame: 1 month
2 secondary outcomes
To compare the accuracy of CTA to CICA in predicting the mode of revascularization (PCI versus CABG) in NSTE-ACS patients.
Time frame: 1 month
To determine the number of "avoidable" CICA (i.e. those accurately designated to medical therapy or surgery with CTA).
Time frame: 1 month
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 26 Jan 2012.
- University of Ottawa Heart InstituteLink provided by the sponsor.
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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.
Carole Dennie, MD study director
The Ottawa Hospital
Derek So, MD study director
Ottawa Heart Institute Research Corporation
Chris Glvoer, MD study director
Univeristy of Ottawa Heart Institute
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 Tomographic Angiography in people with Acute Coronary Syndrome and Non-ST-Elevation Myocardial Infarction, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
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 4 inclusion and 9 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 26 Jan 2012. 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 Canada. 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?
Operating Characteristics of CTA (time frame: 1 month). 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 26 Jan 2012.