Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome

Study Overview
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Brief Summary
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The purpose of this study is to determine if testing patients for endothelial dysfunction will help identify which patients are more likely at risk to have another heart attack in the future. Study participants will undergo mental stress testing while at the same time being connected to a device that measures endothelial function via the Endopat device. These same participants will also undergo a sleep study via the Watchpat device.

Official Title
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The Assessment of Novel Functional Risk Factors for the Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Other: EndoPAT testing (non invasive device)
* Other: WatchPAT testing (non-invasive device)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing revascularization by percutaneous intervention (PCI) for Acute Coronary Syndrome (ACS) at Mayo (STEMI and NonSTEMI patients) Age greater than 18 Exclusion Criteria: Patients likely not to complete the study due to co-morbid conditions (end stage renal disease; liver failure; malignancies) Inability to sign a consent form or availability for follow up Patients unable to tolerate the blood pressure cuff inflation on both arms patients with tremors sustained non-sinus cardiac arrhythmias acrylic finger nails permanent pacemaker color blindness use of alpha blockers and short acting nitrates < 3 hours before study Federal Medical Center inmates

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: vascular testing<br>We are assessing vascular testing in patients presenting with acute coronary syndrome to determine if this type of testing will help identify which patients are more likely at risk to have another heart attack. | Other: EndoPAT testing (non invasive device)<br>* Using the EndoPAT device, we will assess endothelial function.<br>* Other names: Itamar EndoPAT 2000;Other: WatchPAT testing (non-invasive device)<br>* Using the WATCHPAT device we will assess sleep apnea.<br>* Other names: Itamar WatchPAT 200;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unstable Angina, Myocardial Infarction, Repeat Revascularization, Cardiac Death, Stroke |  | Will determine with statistical analysis after all patients have had 2 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Quality of Life as assessed by SF12 | 6 months post revascularization. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Coronary Syndrome (ACS), Percutaneous Intervention (PCI), Coronary Stent (CStent), Percutaneous Transluminal Coronary Angioplasty (PTCA), stent placement, balloon angioplasty