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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01500902

Enrollment

101

Registered

2011-12-29

Start date

2011-09-30

Completion date

2015-04-30

Last updated

2015-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

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

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.

Interventions

OTHEREndoPAT testing (non invasive device)

Using the EndoPAT device, we will assess endothelial function.

OTHERWatchPAT testing (non-invasive device)

Using the WATCHPAT device we will assess sleep apnea.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Unstable Angina, Myocardial Infarction, Repeat Revascularization, Cardiac Death, Stroke	Will determine with statistical analysis after all patients have had 2 year follow-up

Secondary

Measure	Time frame	Description
Quality of Life	6 months post revascularization.	Quality of Life as assessed by SF12

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026