Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome

September 22, 2015 updated by: Amir Lerman, Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.
Other: EndoPAT testing (non invasive device)
Using the EndoPAT device, we will assess endothelial function.
Other Names:
  • Itamar EndoPAT 2000
Other: WatchPAT testing (non-invasive device)
Using the WATCHPAT device we will assess sleep apnea.
Other Names:
  • Itamar WatchPAT 200

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Unstable Angina, Myocardial Infarction, Repeat Revascularization, Cardiac Death, Stroke
Time Frame: Will determine with statistical analysis after all patients have had 2 year follow-up
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
Time Frame: 6 months post revascularization.
Quality of Life as assessed by SF12
6 months post revascularization.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Qatar National Research Fund

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

November 22, 2011

First Submitted That Met QC Criteria

December 28, 2011

First Posted (ESTIMATE)

December 29, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-000047

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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