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Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EndoPAT testing (non invasive device)
WatchPAT testing (non-invasive device)
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Coronary Syndrome focused on measuring Acute Coronary Syndrome (ACS), Percutaneous Intervention (PCI), Coronary Stent (CStent), Percutaneous Transluminal Coronary Angioplasty (PTCA), stent placement, balloon angioplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

vascular testing

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of Life
Quality of Life as assessed by SF12

Full Information

First Posted
November 22, 2011
Last Updated
September 22, 2015
Sponsor
Mayo Clinic
Collaborators
Qatar National Research Fund
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1. Study Identification

Unique Protocol Identification Number
NCT01500902
Brief Title
Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome
Official Title
The Assessment of Novel Functional Risk Factors for the Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Qatar National Research Fund

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Acute Coronary Syndrome (ACS), Percutaneous Intervention (PCI), Coronary Stent (CStent), Percutaneous Transluminal Coronary Angioplasty (PTCA), stent placement, balloon angioplasty

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vascular testing
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
EndoPAT testing (non invasive device)
Other Intervention Name(s)
Itamar EndoPAT 2000
Intervention Description
Using the EndoPAT device, we will assess endothelial function.
Intervention Type
Other
Intervention Name(s)
WatchPAT testing (non-invasive device)
Other Intervention Name(s)
Itamar WatchPAT 200
Intervention Description
Using the WATCHPAT device we will assess sleep apnea.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Quality of Life
Description
Quality of Life as assessed by SF12
Time Frame
6 months post revascularization.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Lerman, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome

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