Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome

This study has been completed.
Qatar National Research Fund
Information provided by (Responsible Party):
Amir Lerman, Mayo Clinic Identifier:
First received: November 22, 2011
Last updated: September 22, 2015
Last verified: September 2015
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.

Condition Intervention
Acute Coronary Syndrome
Other: EndoPAT testing (non invasive device)
Other: WatchPAT testing (non-invasive device)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Assessment of Novel Functional Risk Factors for the Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 6 months post revascularization. ] [ Designated as safety issue: No ]
    Quality of Life as assessed by SF12

Enrollment: 101
Study Start Date: September 2011
Study Completion Date: April 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Itamar EndoPAT 2000
Other: WatchPAT testing (non-invasive device)
Using the WATCHPAT device we will assess sleep apnea.
Other Name: Itamar WatchPAT 200


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01500902

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Qatar National Research Fund
Principal Investigator: Amir Lerman, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Amir Lerman, M.D., Principal Investigator, Mayo Clinic Identifier: NCT01500902     History of Changes
Other Study ID Numbers: 09-000047
Study First Received: November 22, 2011
Last Updated: September 22, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Acute Coronary Syndrome (ACS)
Percutaneous Intervention (PCI)
Coronary Stent (CStent)
Percutaneous Transluminal Coronary Angioplasty (PTCA)
stent placement
balloon angioplasty

Additional relevant MeSH terms:
Acute Coronary Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Heart Diseases
Myocardial Ischemia
Pathologic Processes
Signs and Symptoms
Vascular Diseases processed this record on November 27, 2015