Prevention Trial to Achieve Cardiovascular Targets (IMPACT)

December 30, 2016 updated by: NYU Langone Health

Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University Langone Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Usual care includes physician assistant and/or nurse based medical and lifestyle recommendations in consultation with cardiac catheterization attending or patient's clinical cardiologist to potentially improve the patient's medical and lifestyle regimen. Relevant educational material is routinely distributed to patients.
Active Comparator: Prevention Consult
In addition to usual care, patients will receive a prevention consult by a prevention fellow and attending following their intervention. The consult will include guideline based medical recommendations for optimization of the patient's medical regimen targeting dyslipidemia, hypertension and diabetes. In addition, each patient will be educated on the cardiovascular disease process and given detailed lifestyle recommendations on physical activity, improved nutrition, smoking cessation and medication adherence.
Behavioral: Prevention Consult
In addition to usual care, patients will receive a prevention consult by a prevention fellow and attending following their intervention. The consult will include guideline based medical recommendations for optimization of the patient's medical regimen targeting dyslipidemia, hypertension and diabetes. In addition, each patient will be educated on the cardiovascular disease process and given detailed lifestyle recommendations on physical activity, improved nutrition, smoking cessation and medication adherence.
Active Comparator: Consult & Behavioral Intervention
In addition to usual care and prevention consult (as detailed above), patients will receive a full motivational intervention program by a trained motivational coach and text messages over 6 months.
Behavioral: Consult & Behavioral Intervention
In addition to usual care and prevention consult (as detailed above), patients will receive a full motivational intervention program by a trained motivational coach and text messages over 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of Non-HDL cholesterol
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipids
Time Frame: 6 months
LDL-C, HDL, triglycerides
6 months
Metabolic risk factors
Time Frame: 6 months
weight, BMI, HbA1C, abdominal circumference
6 months
Physical Activity
Time Frame: 6 months
Yale Physical Activity assessment (Part 2)
6 months
Nutrition
Time Frame: 6 months
Northwest Lipid Research Clinic (NWLRC) Fat Intake Score and fruit and vegetable assessment questions
6 months
Medication Adherence
Time Frame: 6 months
Morisky-4 medication adherence survey
6 months
Optimal medical regimen
Time Frame: 6 months
assessment of lipid lowering and cardiovascular medication regimen
6 months
Quality of life
Time Frame: 6 months
Euro Qual 5D survey
6 months
Smoking cessation
Time Frame: 6 months
Patient-based Assessment and Counseling for Physical Activity and Nutrition (PACE) smoking assessment
6 months
Cardiovascular risk
Time Frame: 6 months
cardiovascular risk assessment score (i.e. Framingham)
6 months
Cardiovascular events
Time Frame: 5 years
cardiovascular events and hospitalizations reported by phone call follow-up up to 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

The Rainer Arnhold Foundation

Investigators

  • Principal Investigator: Eugenia Gianos, M.D., NYU Langone Health
  • Principal Investigator: Jeffrey S Berger, MD, MS, NYU Langone Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

July 3, 2012

First Submitted That Met QC Criteria

July 14, 2012

First Posted (Estimate)

July 17, 2012

Study Record Updates

Last Update Posted (Estimate)

January 2, 2017

Last Update Submitted That Met QC Criteria

December 30, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMPACT-2012-400

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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