Low Risk Acute Coronary Syndrome

Low Risk Acute Coronary Syndrome Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01703156
• Other study ID #: Low Risk ACS
• Secondary ID: IRB#14542
• Status: Completed
• Phase: N/A
• First received: October 3, 2012
• Last updated: April 10, 2017
• Start date: May 2009
• Est. completion date: July 2012

Study information

• Verified date: April 2017
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Low Risk Acute Coronary Syndrome
• Syndrome

Intervention

Procedure:
• Stress Test

• No Stress Test

Locations

Country	Name	City	State
United States	Veteran's Affairs Medical Center	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	one year
Secondary	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.	one year