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OpenTrials
Completed

NCT Number: NCT01703156

Low Risk Acute Coronary Syndrome

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.

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Key information

Conditions

Low Risk Acute Coronary Syndrome Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Veteran's Affairs Medical Center

Oklahoma City, Oklahoma, 73104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Stress Test

Procedure

No Stress Test

Procedure

Primary outcomes

  1. 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).

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.

    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.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • VA Office of Research and Development

Registry information

Official study title

Stress Testing Versus Non-Stress Testing Based Strategy in Patients Hospitalized With Low-Risk Acute Coronary Syndromes: A Randomized, Single-Center Pilot Study

Acronym: LOW ACT

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Oct 10, 2012
Registry last updated
Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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