Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome

NCT01500902 | Completed

• 1 other identifier: 09-000047
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Keywords

Acute Coronary Syndrome (ACS); Percutaneous Intervention (PCI); Coronary Stent (CStent); Percutaneous Transluminal Coronary Angioplasty (PTCA); stent placement; balloon angioplasty

Outcome Measures

Primary Outcomes (1)

• Unstable Angina, Myocardial Infarction, Repeat Revascularization, Cardiac Death, Stroke

  Will determine with statistical analysis after all patients have had 2 year follow-up

Secondary Outcomes (1)

• Quality of Life

  6 months post revascularization.

Study Arms (1)

vascular testing

OTHER

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); Other: WatchPAT testing (non-invasive device)

Interventions

EndoPAT testing (non invasive device) OTHER

Using the EndoPAT device, we will assess endothelial function.

Also known as: Itamar EndoPAT 2000

vascular testing

WatchPAT testing (non-invasive device) OTHER

Using the WATCHPAT device we will assess sleep apnea.

Also known as: Itamar WatchPAT 200

vascular testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing revascularization by percutaneous intervention (PCI) for Acute Coronary Syndrome (ACS) at Mayo (STEMI and NonSTEMI patients)
• Age greater than 18

You may not qualify if:

• Patients likely not to complete the study due to co-morbid conditions (end stage renal disease; liver failure; malignancies)
• Inability to sign a consent form or availability for follow up
• Patients unable to tolerate the blood pressure cuff inflation on both arms
• patients with tremors
• sustained non-sinus cardiac arrhythmias
• acrylic finger nails
• permanent pacemaker
• color blindness
• use of alpha blockers and short acting nitrates \< 3 hours before study
• Federal Medical Center inmates

Sponsors & Collaborators

• Mayo Clinic: lead
• Qatar National Research Fund: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Amir Lerman, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Principal Investigator

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: December 29, 2011
• Study Start: September 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2015
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

US (1)