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Clinical Trials/NCT01500902
NCT01500902
Completed
Not Applicable

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

Mayo Clinic1 site in 1 country101 target enrollmentSeptember 2011
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ConditionsAcute Coronary Syndrome

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Coronary Syndrome
Sponsor
Mayo Clinic
Enrollment
101
Locations
1
Primary Endpoint
Unstable Angina, Myocardial Infarction, Repeat Revascularization, Cardiac Death, Stroke
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
April 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amir Lerman

M.D., Principal Investigator

Mayo Clinic

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Quality of Life(6 months post revascularization.)

Study Sites (1)

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