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Clinical Trials/NCT01642355
NCT01642355
Completed
N/A

Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets

NYU Langone Health1 site in 1 country400 target enrollmentJune 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
NYU Langone Health
Enrollment
400
Locations
1
Primary Endpoint
Reduction of Non-HDL cholesterol
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The objective of IMPACT (Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets) is to determine the best management strategy for patients undergoing cardiovascular intervention. IMPACT is a prospective randomized trial that will enroll 400 patients post-cardiovascular intervention. The study will compare different cardiovascular prevention strategies: (1) usual care, (2) cardiovascular prevention consult, and (3) cardiovascular prevention consult with a behavioral intervention program over a 6-month period. The trial hypothesis is that for patients undergoing a cardiovascular intervention, a prevention consult and behavioral intervention is superior to usual care in reducing cardiovascular risk. The primary endpoint will be non-HDL cholesterol. Secondary endpoints include other lipid values, metabolic risk, smoking cessation, physical activity, nutritional status, medication adherence and quality of life. IMPACT is scheduled to begin enrollment in the June of 2012.

Detailed Description

SPECIFIC AIMS Primary aim: The primary aim is that a targeted Cardiovascular Prevention consult will reduce non-HDL cholesterol compared to usual care at 6 months post-intervention. Secondary aim: The secondary aim is that a targeted Cardiovascular Prevention consult plus a behavioral intervention will reduce non-HDL cholesterol compared to usual care at 6 months post-intervention.

Registry
clinicaltrials.gov
Start Date
June 2012
End Date
May 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • at least 21 years of age or older
  • Subjects scheduled to undergo a percutaneous coronary or peripheral vascular intervention
  • Patients must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

  • Life expectancy less than 1-year
  • Inability to walk

Outcomes

Primary Outcomes

Reduction of Non-HDL cholesterol

Time Frame: 6 months

Secondary Outcomes

  • Nutrition(6 months)
  • Metabolic risk factors(6 months)
  • Physical Activity(6 months)
  • Quality of life(6 months)
  • Smoking cessation(6 months)
  • Optimal medical regimen(6 months)
  • Cardiovascular risk(6 months)
  • Cardiovascular events(5 years)
  • Lipids(6 months)
  • Medication Adherence(6 months)

Study Sites (1)

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