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Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01500902
First Posted: December 29, 2011
Last Update Posted: September 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Qatar National Research Fund
Information provided by (Responsible Party):
Amir Lerman, Mayo Clinic
  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: 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

Further study details as provided by Amir Lerman, 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 ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 6 months post revascularization. ]
    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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Amir Lerman, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01500902     History of Changes
Other Study ID Numbers: 09-000047
First Submitted: November 22, 2011
First Posted: December 29, 2011
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