Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome

This study is currently recruiting participants.

Verified October 2012 by Mayo Clinic

Sponsor:

Collaborator:

Qatar National Research Fund

Information provided by (Responsible Party):

Amir Lerman, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT01500902

First received: November 22, 2011

Last updated: October 23, 2012

Last verified: October 2012

History of Changes

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:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of Life [ Time Frame: 6 months post revascularization. ] [ Designated as safety issue: No ]
Quality of Life as assessed by SF12

Estimated Enrollment:	544
Study Start Date:	September 2011
Estimated Study Completion Date:	September 2015
Estimated Primary Completion Date:	September 2014 (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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01500902

Contacts

Contact: Rebecca E. Nelson, CCRC	507-255-8388	nelson.rebecca@mayo.edu
Contact: Sarah Shonyo	507-255-2648	shonyo.sarah@mayo.edu

Locations

United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Rebecca E. Nelson, CCRC 507-255-8388
Principal Investigator: Amir Lerman, M.D.

Sponsors and Collaborators

Mayo Clinic

Qatar National Research Fund

Investigators

Principal Investigator:

Amir Lerman, M.D.

Mayo Clinic

More Information

No publications provided

Responsible Party:	Amir Lerman, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT01500902 History of Changes
Other Study ID Numbers:	09-000047
Study First Received:	November 22, 2011
Last Updated:	October 23, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

ACS
PCI
CStent

PTCA
stent placement
balloon angioplasty

Additional relevant MeSH terms:

Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris

Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013

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