Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 8, 2014
Last verified: May 2014
  Purpose

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

Resource links provided by NLM:


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


Estimated Enrollment: 544
Study Start Date: September 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01500902

Contacts
Contact: Rebecca E. Nelson, CCRC 507-255-8388 nelson.rebecca@mayo.edu
Contact: Sarah Shonyo 507-255-2648 shonyo.sarah@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Rebecca E. Nelson, CCRC    507-255-8388      
Principal Investigator: Amir Lerman, M.D.         
Sponsors and Collaborators
Mayo Clinic
Qatar National Research Fund
Investigators
Principal Investigator: Amir Lerman, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Amir Lerman, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01500902     History of Changes
Other Study ID Numbers: 09-000047
Study First Received: November 22, 2011
Last Updated: May 8, 2014
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
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014