Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome

NCT ID: NCT01500902

Last Updated: 2015-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-04-30

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.

Detailed Description

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Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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vascular testing

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.

Group Type OTHER

EndoPAT testing (non invasive device)

Intervention Type OTHER

Using the EndoPAT device, we will assess endothelial function.

WatchPAT testing (non-invasive device)

Intervention Type OTHER

Using the WATCHPAT device we will assess sleep apnea.

Interventions

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EndoPAT testing (non invasive device)

Using the EndoPAT device, we will assess endothelial function.

Intervention Type OTHER

WatchPAT testing (non-invasive device)

Using the WATCHPAT device we will assess sleep apnea.

Intervention Type OTHER

Other Intervention Names

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Itamar EndoPAT 2000 Itamar WatchPAT 200

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qatar National Research Fund

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Amir Lerman

M.D., Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amir Lerman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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09-000047

Identifier Type: -

Identifier Source: org_study_id

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