Prevention Trial to Achieve Cardiovascular Targets

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Peripheral Arterial Disease; Hypertension; Obesity; Hyperlipidemia; Diabetes; Prediabetes
• Interventions: Behavioral: Consult & Behavioral Intervention; Behavioral: Prevention Consult

• Registration Number: NCT01642355
• Lead Sponsor: NYU Langone Health

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-07-03
• Study First Submitted QC: 2012-07-14
• Study First Posted: 2012-07-17
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-30
• Last Update Posted: 2017-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Consult & Behavioral Intervention	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.
Prevention Consult	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.

Primary Outcome Measures

Name	Time	Method
Reduction of Non-HDL cholesterol	6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

New York University Langone Medical Center; 🇺🇸 New York, New York, United States