Low Risk Acute Coronary SyndromeLOW ACTNCT01703156
Low Risk Acute Coronary Syndrome
A study testing Stress Test and No Stress Test in people with Low Risk Acute Coronary Syndrome, run by University of Oklahoma at 1 site in United States.
Trial summary
A large number of patients are diagnosed with low risk ACS, and these individuals are at significant cardiovascular risk. Though guidelines recommend stress testing to manage low risk ACS patients, evidence supporting this recommendation is not based on trials examining this population. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Low Risk Acute Coronary Syndrome
- What is being tested?
- Stress Test and No Stress Test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Jul 2012
- 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
- TIMI score < or = to 2(12)
- TIMI risk score of 3 with no known CAD, greater than 50% in one or more vessels
- Normal cardiac biomarkers (3 sets over 12-88 hours)
- No evidence of acute ischemia on electrocardiograms
- Normal ejection fraction (>40%) on echocardiography
- Age 30-75
- Ability to complete noninvasive stress test
- Ability to provide informed consent
Who cannot join
- Presence of another medical condition to explain chest pain or non-cardiac chest pain (i.e. pneumonia, costochondritis)
- Any patient who is initially classified as low risk but whom develops recurrent symptoms of ischemia, hemodynamic instability, or arrhythmias attributable to ischemia
- Evidence of ischemia on electrocardiogram
- Abnormal cardiac biomarkers
- History of medical noncompliance or social circumstances preventing compliance
- Life span estimated at <1 year
- Pregnancy
- Refusal to sign consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Veteran's Affairs Medical Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Stress Testing Versus Non-Stress Testing Based Strategy in Patients Hospitalized With Low-Risk Acute Coronary Syndromes: A Randomized, Single-Center Pilot Study
A large number of patients are diagnosed with low risk ACS, and these individuals are at significant cardiovascular risk. Though guidelines recommend stress testing to manage low risk ACS patients, evidence supporting this recommendation is not based on trials examining this population. A well-designed, randomized trial is warranted to determine if stress testing is useful in managing low risk ACS. If medical therapy alone is equivalent as the investigators hypothesize, healthcare expenditures could be reduced and patients may not be exposed to the harms associated with more invasive cardiac testing such as coronary angiography.
- Conditions
- Low Risk Acute Coronary Syndrome
- Being tested
- Stress Test, No Stress Test
- Keywords
- Low Risk ACS, Acute Coronary Syndrome, Stress Testing, Non-Stress Testing
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress TestProcedure or surgery
No Stress TestProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Non-Stress Group | Experimental | Medical therapy will be implemented and will include the following: aspirin, clopidogrel, b-blockers, and statins. The dosages of aspirin, b-blocker and statin will be left to the discretion of the treating physician. Statins will be initiated irrespective of LDL unless contraindicated. Clopidogrel will be taken for at least one month and ideally up to one year. Sublingual nitroglycerin will be provided to all patients. Other anti-ischemic medications including long-acting nitrates, calcium channel blockers, and ranolazine may be provided at the treating physicians' discretion. If a patient has contraindications to any medications, they will not be administered. If a statin contraindication exists, other cholesterol-lowering medications may be administered. Appendix 4 shows the detailed management of low risk ACS patients randomized to the non-stress group. Receives: Procedure: No Stress Test |
| Stress Group | Active comparator | Medical therapy will be implemented and will include the following: aspirin, clopidogrel, b-blockers, and statins. Statins will be initiated irrespective of LDL unless contraindicated. Clopidogrel will be taken for at least one month and ideally up to one year. Sublingual nitroglycerin will be provided to all patients. Other anti-ischemic medications including long-acting nitrates, calcium channel blockers, and ranolazine may be provided at the treating physicians' discretion. If a statin contraindication exists, other cholesterol-lowering medications may be administered. All patients will undergo noninvasive stress testing. Results of individual stress tests will be reviewed by a cardiologist. Based on the myocardium deemed at risk and patient symptoms, further testing with angiography and revascularization using percutaneous techniques and/or coronary artery bypass grafting may be considered. Likewise, medical treatment may be adjusted. Receives: Procedure: Stress Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause mortality, hospitalization for UA/NSTEMI or STEMI, and urgent revascularization
Primary endpoints include the composite of all-cause mortality, hospitalization for Unstable Angina/Non ST-Elevation Myocardial Infarction (UA/NSTEMI) or ST-Elevation Myocardial Infarction (STEMI), and urgent revascularization (coronary artery bypass grafting or percutaneous coronary intervention).
Measured: one year
Secondary outcomes (1)
Secondary endpoints will include mortality, UA/NSTEMI or STEMI, coronary revascularization, unplanned diagnostic coronary angiography, noninvasive stress testing, medication adjustments, and medication side effects.
Secondary endpoints will include: mortality, UA/NSTEMI or STEMI, coronary revascularization, unplanned diagnostic coronary angiography, noninvasive stress testing, medication adjustments, and medication side effects.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2012 (estimated)
- Study startMay 2009
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Risk 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- VA Office of Research and Development
- Responsible party
- Principal investigator, Mazen Abu-Fadel, M.D., University of Oklahoma
- Investigators
- Mazen S Abu-Fadel, MD, FACC, FSCAI, Principal investigator, OUHSC and VAMC OKC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703156
- Sponsor's protocol ID
- Low Risk ACS
- Other IDs
- IRB#14542
- Acronym
- LOW ACT
- Status last verified
- Apr 2017
- First submitted
- 3 Oct 2012
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Testing Versus Non-Stress Testing Based Strategy in Patients Hospitalized With Low-Risk Acute Coronary Syndromes: A Randomized, Single-Center Pilot Study
- ClinicalTrials.gov ID
- NCT01703156
- Acronym / sponsor ID
- LOW ACT / Low Risk ACS
- Conditions
- Low Risk Acute Coronary Syndrome
- Keywords
- Low Risk ACS, Acute Coronary Syndrome, Stress Testing, Non-Stress Testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- VA Office of Research and Development
- Study start
- May 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 10 Oct 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.
A large number of patients are diagnosed with low risk ACS, and these individuals are at significant cardiovascular risk. Though guidelines recommend stress testing to manage low risk ACS patients, evidence supporting this recommendation is not based on trials examining this population. A well-designed, randomized trial is warranted to determine if stress testing is useful in managing low risk ACS. If medical therapy alone is equivalent as the investigators hypothesize, healthcare expenditures could be reduced and patients may not be exposed to the harms associated with more invasive cardiac testing such as coronary angiography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Stress Group | Experimental | Procedure: No Stress TestMedical therapy will be implemented and will include the following: aspirin, clopidogrel, b-blockers, and statins. The dosages of aspirin, b-blocker and statin will be left to the discretion of the treating physician. Statins will be initiated irrespective of LDL unless contraindicated. Clopidogrel will be taken for at least one month and ideally up to one year. Sublingual nitroglycerin will be provided to all patients. Other anti-ischemic medications including long-acting nitrates, calcium channel blockers, and ranolazine may be provided at the treating physicians' discretion. If a patient has contraindications to any medications, they will not be administered. If a statin contraindication exists, other cholesterol-lowering medications may be administered. Appendix 4 shows the detailed management of low risk ACS patients randomized to the non-stress group. |
| Stress Group | Active comparator | Procedure: Stress TestMedical therapy will be implemented and will include the following: aspirin, clopidogrel, b-blockers, and statins. Statins will be initiated irrespective of LDL unless contraindicated. Clopidogrel will be taken for at least one month and ideally up to one year. Sublingual nitroglycerin will be provided to all patients. Other anti-ischemic medications including long-acting nitrates, calcium channel blockers, and ranolazine may be provided at the treating physicians' discretion. If a statin contraindication exists, other cholesterol-lowering medications may be administered. All patients will undergo noninvasive stress testing. Results of individual stress tests will be reviewed by a cardiologist. Based on the myocardium deemed at risk and patient symptoms, further testing with angiography and revascularization using percutaneous techniques and/or coronary artery bypass grafting may be considered. Likewise, medical treatment may be adjusted. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- TIMI score < or = to 2(12)
- TIMI risk score of 3 with no known CAD, greater than 50% in one or more vessels
- Normal cardiac biomarkers (3 sets over 12-88 hours)
- No evidence of acute ischemia on electrocardiograms
- Normal ejection fraction (>40%) on echocardiography
Key exclusion criteria (8 listed)
- Presence of another medical condition to explain chest pain or non-cardiac chest pain (i.e. pneumonia, costochondritis)
- Any patient who is initially classified as low risk but whom develops recurrent symptoms of ischemia, hemodynamic instability, or arrhythmias attributable to ischemia
- Evidence of ischemia on electrocardiogram
- Abnormal cardiac biomarkers
- History of medical noncompliance or social circumstances preventing compliance
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 |
|---|---|---|
| Stress Test | Procedure or surgery | Stress Group |
| No Stress Test | Procedure or surgery | Non-Stress Group |
Primary outcome
Composite of all-cause mortality, hospitalization for UA/NSTEMI or STEMI, and urgent revascularization
Time frame: one year
Primary endpoints include the composite of all-cause mortality, hospitalization for Unstable Angina/Non ST-Elevation Myocardial Infarction (UA/NSTEMI) or ST-Elevation Myocardial Infarction (STEMI), and urgent revascularization (coronary artery bypass grafting or percutaneous coronary intervention).
1 secondary outcome
Secondary endpoints will include mortality, UA/NSTEMI or STEMI, coronary revascularization, unplanned diagnostic coronary angiography, noninvasive stress testing, medication adjustments, and medication side effects.
Time frame: one year
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 12 Apr 2017.
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.
Mazen S Abu-Fadel, MD, FACC, FSCAI principal investigator
OUHSC and VAMC OKC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Test and No Stress Test in people with Low Risk Acute Coronary Syndrome, run by University of Oklahoma at 1 site in United States.
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 8 inclusion and 8 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 12 Apr 2017. 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 United States. 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?
Composite of all-cause mortality, hospitalization for UA/NSTEMI or STEMI, and urgent revascularization (time frame: one year). 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 12 Apr 2017; AzTrials last refreshed its copy on 1 Nov 2026.