search
Back to results

Prevention Trial to Achieve Cardiovascular Targets (IMPACT)

Primary Purpose

Coronary Artery Disease, Peripheral Arterial Disease, Hyperlipidemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prevention Consult
Consult & Behavioral Intervention
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease

Eligibility Criteria

21 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York University Langone Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Usual Care

Prevention Consult

Consult & Behavioral Intervention

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Reduction of Non-HDL cholesterol

Secondary Outcome Measures

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

Full Information

First Posted
July 3, 2012
Last Updated
December 30, 2016
Sponsor
NYU Langone Health
Collaborators
The Rainer Arnhold Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT01642355
Brief Title
Prevention Trial to Achieve Cardiovascular Targets
Acronym
IMPACT
Official Title
Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
The Rainer Arnhold Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Peripheral Arterial Disease, Hyperlipidemia, Hypertension, Diabetes, Prediabetes, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Prevention Consult
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Consult & Behavioral Intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Prevention Consult
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Consult & Behavioral Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction of Non-HDL cholesterol
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Lipids
Description
LDL-C, HDL, triglycerides
Time Frame
6 months
Title
Metabolic risk factors
Description
weight, BMI, HbA1C, abdominal circumference
Time Frame
6 months
Title
Physical Activity
Description
Yale Physical Activity assessment (Part 2)
Time Frame
6 months
Title
Nutrition
Description
Northwest Lipid Research Clinic (NWLRC) Fat Intake Score and fruit and vegetable assessment questions
Time Frame
6 months
Title
Medication Adherence
Description
Morisky-4 medication adherence survey
Time Frame
6 months
Title
Optimal medical regimen
Description
assessment of lipid lowering and cardiovascular medication regimen
Time Frame
6 months
Title
Quality of life
Description
Euro Qual 5D survey
Time Frame
6 months
Title
Smoking cessation
Description
Patient-based Assessment and Counseling for Physical Activity and Nutrition (PACE) smoking assessment
Time Frame
6 months
Title
Cardiovascular risk
Description
cardiovascular risk assessment score (i.e. Framingham)
Time Frame
6 months
Title
Cardiovascular events
Description
cardiovascular events and hospitalizations reported by phone call follow-up up to 5 years
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugenia Gianos, M.D.
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey S Berger, MD, MS
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26385025
Citation
Gianos E, Schoenthaler A, Mushailov M, Fisher EA, Berger JS. Rationale and design of the Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets (IMPACT) trial. Am Heart J. 2015 Sep;170(3):430-7.e9. doi: 10.1016/j.ahj.2015.06.001. Epub 2015 Jun 6.
Results Reference
background
PubMed Identifier
29754664
Citation
Gianos E, Schoenthaler A, Guo Y, Zhong J, Weintraub H, Schwartzbard A, Underberg J, Schloss M, Newman JD, Heffron S, Fisher EA, Berger JS. Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets (IMPACT) trial. Am Heart J. 2018 May;199:37-43. doi: 10.1016/j.ahj.2017.12.019. Epub 2018 Jan 9.
Results Reference
derived
Links:
URL
http://www.med.nyu.edu/cvprevention/
Description
New York University Langone Center for the Prevention of Cardiovascular Disease website

Learn more about this trial

Prevention Trial to Achieve Cardiovascular Targets

We'll reach out to this number within 24 hrs