Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

Official title:

The Assessment of Novel Functional Risk Factors for the Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01500902
• Other study ID #: 09-000047
• Status: Completed
• Phase: N/A
• First received: November 22, 2011
• Last updated: September 22, 2015
• Start date: September 2011
• Est. completion date: April 2015

Study information

• Verified date: September 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Other:
• EndoPAT testing (non invasive device)
Using the EndoPAT device, we will assess endothelial function.
• WatchPAT testing (non-invasive device)
Using the WATCHPAT device we will assess sleep apnea.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Qatar National Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unstable Angina, Myocardial Infarction, Repeat Revascularization, Cardiac Death, Stroke		Will determine with statistical analysis after all patients have had 2 year follow-up	No
Secondary	Quality of Life	Quality of Life as assessed by SF12	6 months post revascularization.	No