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OpenTrials
Completed

NCT Number: NCT01500902

Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

EndoPAT testing (non invasive device)

Other

Using the EndoPAT device, we will assess endothelial function.

Other names: Itamar EndoPAT 2000

WatchPAT testing (non-invasive device)

Other

Using the WATCHPAT device we will assess sleep apnea.

Other names: Itamar WatchPAT 200

Primary outcomes

  1. 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 outcomes

  1. Quality of Life

    Time frame: 6 months post revascularization.

    Quality of Life as assessed by SF12

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Qatar National Research Fund

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Dec 29, 2011
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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