Prevention Trial to Achieve Cardiovascular Targets (IMPACT)

NYU Langone Health

Status: Completed

Conditions: Prediabetes; Hypertension; Coronary Artery Disease; Diabetes; Hyperlipidemia; Obesity; Peripheral Arterial Disease

Treatments: Behavioral: Consult & Behavioral Intervention; Behavioral: Prevention Consult

Study type: Interventional

Funder types: Other

Identifiers

NCT01642355

IMPACT-2012-400

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 21 to 99 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 3 patient groups

Usual Care

No Intervention group

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.

Prevention Consult

Active Comparator group

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.

Treatment:

Behavioral: Prevention Consult

Consult & Behavioral Intervention

Active Comparator group

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.

Treatment:

Behavioral: Consult & Behavioral Intervention