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Low Risk Acute Coronary Syndrome (LOW ACT)

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ClinicalTrials.gov Identifier: NCT01703156
Recruitment Status : Completed
First Posted : October 10, 2012
Last Update Posted : April 12, 2017
Sponsor:
Collaborator:
VA Office of Research and Development
Information provided by (Responsible Party):
Mazen Abu-Fadel, M.D., University of Oklahoma

October 3, 2012
October 10, 2012
April 12, 2017
May 2009
July 2012   (Final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01703156 on ClinicalTrials.gov Archive Site
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 ]
Secondary endpoints will include: mortality, UA/NSTEMI or STEMI, coronary revascularization, unplanned diagnostic coronary angiography, noninvasive stress testing, medication adjustments, and medication side effects.
Same as current
Not Provided
Not Provided
 
Low Risk Acute Coronary Syndrome
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Low Risk Acute Coronary Syndrome
  • Procedure: Stress Test
  • Procedure: No Stress Test
  • Experimental: Non-Stress Group
    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.
    Intervention: Procedure: No Stress Test
  • Active Comparator: Stress Group
    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.
    Intervention: Procedure: Stress Test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
Same as current
July 2012
July 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. TIMI score < or = to 2(12)
  2. TIMI risk score of 3 with no known CAD, greater than 50% in one or more vessels
  3. Normal cardiac biomarkers (3 sets over 12-88 hours)
  4. No evidence of acute ischemia on electrocardiograms
  5. Normal ejection fraction (>40%) on echocardiography
  6. Age 30-75
  7. Ability to complete noninvasive stress test
  8. Ability to provide informed consent

Exclusion Criteria:

  1. Presence of another medical condition to explain chest pain or non-cardiac chest pain (i.e. pneumonia, costochondritis)
  2. Any patient who is initially classified as low risk but whom develops recurrent symptoms of ischemia, hemodynamic instability, or arrhythmias attributable to ischemia
  3. Evidence of ischemia on electrocardiogram
  4. Abnormal cardiac biomarkers
  5. History of medical noncompliance or social circumstances preventing compliance
  6. Life span estimated at <1 year
  7. Pregnancy
  8. Refusal to sign consent
Sexes Eligible for Study: All
30 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01703156
Low Risk ACS
IRB#14542 ( Other Identifier: University of Oklahoma Health Sciences Center Institutional Review Board )
Yes
Not Provided
Not Provided
Mazen Abu-Fadel, M.D., University of Oklahoma
University of Oklahoma
VA Office of Research and Development
Principal Investigator: Mazen S Abu-Fadel, MD, FACC, FSCAI OUHSC and VAMC OKC
University of Oklahoma
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP