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Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome

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ClinicalTrials.gov Identifier: NCT01500902
Recruitment Status : Completed
First Posted : December 29, 2011
Last Update Posted : September 23, 2015
Sponsor:
Collaborator:
Qatar National Research Fund
Information provided by (Responsible Party):
Amir Lerman, 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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Other: EndoPAT testing (non invasive device) Other: WatchPAT testing (non-invasive device) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2011
Actual Primary Completion Date : March 2015
Actual Study Completion Date : April 2015

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Quality of Life [ Time Frame: 6 months post revascularization. ]
    Quality of Life as assessed by SF12



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01500902


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

Responsible Party: Amir Lerman, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01500902     History of Changes
Other Study ID Numbers: 09-000047
First Posted: December 29, 2011    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by Amir Lerman, 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:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases