Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome

Not Applicable

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Other: EndoPAT testing (non invasive device); Other: WatchPAT testing (non-invasive device)

• Registration Number: NCT01500902
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-11-22
• Study First Submitted QC: 2011-12-28
• Study First Posted: 2011-12-29
• Primary Completion: 2015-03
• Study Completion: 2015-04
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-22
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

1. Patients undergoing revascularization by percutaneous intervention (PCI) for Acute Coronary Syndrome (ACS) at Mayo (STEMI and NonSTEMI patients)
2. Age greater than 18

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Exclusion Criteria

1. Patients likely not to complete the study due to co-morbid conditions (end stage renal disease; liver failure; malignancies)
2. Inability to sign a consent form or availability for follow up
3. Patients unable to tolerate the blood pressure cuff inflation on both arms
4. patients with tremors
5. sustained non-sinus cardiac arrhythmias
6. acrylic finger nails
7. permanent pacemaker
8. color blindness
9. use of alpha blockers and short acting nitrates < 3 hours before study
10. Federal Medical Center inmates

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vascular testing	EndoPAT testing (non invasive device)	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.
vascular testing	WatchPAT testing (non-invasive device)	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Quality of Life	6 months post revascularization.	Quality of Life as assessed by SF12

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States