Low Risk Acute Coronary Syndrome (LOW ACT)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mazen Abu-Fadel, M.D., University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01703156
First received: October 3, 2012
Last updated: October 9, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Low Risk Acute Coronary Syndrome
Procedure: Stress Test
Procedure: No Stress Test
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Composite of all-cause mortality, hospitalization for UA/NSTEMI or STEMI, and urgent revascularization [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Secondary endpoints will include: mortality, UA/NSTEMI or STEMI, coronary revascularization, unplanned diagnostic coronary angiography, noninvasive stress testing, medication adjustments, and medication side effects.


Enrollment: 70
Study Start Date: May 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Procedure: Stress Test

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01703156

Locations
United States, Oklahoma
Veteran's Affairs Medical Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Mazen S Abu-Fadel, MD, FACC, FSCAI OUHSC and VAMC OKC
  More Information

No publications provided

Responsible Party: Mazen Abu-Fadel, M.D., Associate Professor of Medicine, University of Oklahoma
ClinicalTrials.gov Identifier: NCT01703156     History of Changes
Other Study ID Numbers: Low Risk ACS, IRB#14542
Study First Received: October 3, 2012
Last Updated: October 9, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Oklahoma:
Low Risk ACS, Acute Coronary Syndrome, Stress Testing, Non-Stress Testing

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014