Low Risk Acute Coronary Syndrome

NCT01703156 | Completed DMC

• 2 other identifiers: Low Risk ACSIRB#14542
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Risk Acute Coronary Syndrome

Keywords

Low Risk ACS, Acute Coronary Syndrome, Stress Testing, Non-Stress Testing

Outcome Measures

Primary Outcomes (1)

• 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 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.

  one year

Study Arms (2)

Non-Stress Group

EXPERIMENTAL

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

Stress Group

ACTIVE COMPARATOR

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

Interventions

Stress Test PROCEDURE

Stress Group

No Stress Test PROCEDURE

Non-Stress Group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead
• VA Office of Research and Development: collaborator

Study Sites (1)

Veteran's Affairs Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Mazen S Abu-Fadel, MD, FACC, FSCAI

  OUHSC and VAMC OKC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: October 3, 2012
• First Posted: October 10, 2012
• Study Start: May 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 12, 2017

Record last verified: 2017-04

Locations

US (1)