Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome

This study is currently recruiting participants.
Verified June 2013 by Mayo Clinic
Sponsor:
Collaborator:
Qatar National Research Fund
Information provided by (Responsible Party):
Amir Lerman, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01500902
First received: November 22, 2011
Last updated: June 24, 2013
Last verified: June 2013

November 22, 2011
June 24, 2013
September 2011
September 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01500902 on ClinicalTrials.gov Archive Site
Quality of Life [ Time Frame: 6 months post revascularization. ] [ Designated as safety issue: No ]
Quality of Life as assessed by SF12
Same as current
Not Provided
Not Provided
 
Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Acute Coronary Syndrome
  • 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
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.
Interventions:
  • Other: EndoPAT testing (non invasive device)
  • Other: WatchPAT testing (non-invasive device)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
544
September 2015
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Rebecca E. Nelson, CCRC 507-255-8388 nelson.rebecca@mayo.edu
Contact: Sarah Shonyo 507-255-2648 shonyo.sarah@mayo.edu
United States
 
NCT01500902
09-000047
No
Amir Lerman, Mayo Clinic
Mayo Clinic
Qatar National Research Fund
Principal Investigator: Amir Lerman, M.D. Mayo Clinic
Mayo Clinic
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP