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Low Risk Acute Coronary Syndrome (LOW ACT)

Primary Purpose

Low Risk Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stress Test
No Stress Test
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Low Risk Acute Coronary Syndrome focused on measuring Low Risk ACS, Acute Coronary Syndrome, Stress Testing, Non-Stress Testing

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Veteran's Affairs Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Non-Stress Group

Stress Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

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.
Secondary endpoints will include: mortality, UA/NSTEMI or STEMI, coronary revascularization, unplanned diagnostic coronary angiography, noninvasive stress testing, medication adjustments, and medication side effects.

Full Information

First Posted
October 3, 2012
Last Updated
April 10, 2017
Sponsor
University of Oklahoma
Collaborators
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01703156
Brief Title
Low Risk Acute Coronary Syndrome
Acronym
LOW ACT
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oklahoma
Collaborators
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Risk Acute Coronary Syndrome
Keywords
Low Risk ACS, Acute Coronary Syndrome, Stress Testing, Non-Stress Testing

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-Stress Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Stress Group
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Stress Test
Intervention Type
Procedure
Intervention Name(s)
No Stress Test
Primary Outcome Measure Information:
Title
Composite of all-cause mortality, hospitalization for UA/NSTEMI or STEMI, and urgent revascularization
Description
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).
Time Frame
one year
Secondary Outcome Measure Information:
Title
Secondary endpoints will include mortality, UA/NSTEMI or STEMI, coronary revascularization, unplanned diagnostic coronary angiography, noninvasive stress testing, medication adjustments, and medication side effects.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mazen S Abu-Fadel, MD, FACC, FSCAI
Organizational Affiliation
OUHSC and VAMC OKC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veteran's Affairs Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

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Low Risk Acute Coronary Syndrome

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