Prediction of Cardiovascular Events in Vulnerable Patient... | NCT01500902

Studies
Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome

NCT01500902

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Sep 23, 2015Estimated

Enrollment

101Actual

Phase

Not Applicable

Conditions

Acute Coronary Syndrome

Interventions

EndoPAT testing (non invasive device)
WatchPAT testing (non-invasive device)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Mar 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Nov 22, 2011

First Submission Date that Met QC Criteria

Dec 28, 2011

First Posted Date

Dec 29, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2015

Last Update Posted Date

Sep 23, 2015Estimated

Name	Class
Qatar National Research Fund	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

101Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
vascular testing	Other	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) Other: WatchPAT testing (non-invasive device)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EndoPAT testing (non invasive device)	Other	Using the EndoPAT device, we will assess endothelial function.	vascular testing

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amir Lerman, M.D.	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Rochester	Minnesota	55905	United States

Condition Browse Module

MeSH Terms

ID	Term
D054058	Acute Coronary Syndrome

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided