Skip to main content
OpenTrials
Completed

NCT Number: NCT01642355

Prevention Trial 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Body Weight Cardiovascular Diseases Coronary Disease Diabetes Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Hyperlipidemia Hyperlipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases PreDiabetes Prediabetic State Signs and Symptoms Vascular Diseases

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University Langone Medical Center

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prevention Consult

Behavioral

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.

Consult & Behavioral Intervention

Behavioral

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 outcomes

  1. Reduction of Non-HDL cholesterol

    Time frame: 6 months

Secondary outcomes

  1. Lipids

    Time frame: 6 months

    LDL-C, HDL, triglycerides

  2. Metabolic risk factors

    Time frame: 6 months

    weight, BMI, HbA1C, abdominal circumference

  3. Physical Activity

    Time frame: 6 months

    Yale Physical Activity assessment (Part 2)

  4. Nutrition

    Time frame: 6 months

    Northwest Lipid Research Clinic (NWLRC) Fat Intake Score and fruit and vegetable assessment questions

  5. Medication Adherence

    Time frame: 6 months

    Morisky-4 medication adherence survey

  6. Optimal medical regimen

    Time frame: 6 months

    assessment of lipid lowering and cardiovascular medication regimen

  7. Quality of life

    Time frame: 6 months

    Euro Qual 5D survey

  8. Smoking cessation

    Time frame: 6 months

    Patient-based Assessment and Counseling for Physical Activity and Nutrition (PACE) smoking assessment

  9. Cardiovascular risk

    Time frame: 6 months

    cardiovascular risk assessment score (i.e. Framingham)

  10. Cardiovascular events

    Time frame: 5 years

    cardiovascular events and hospitalizations reported by phone call follow-up up to 5 years

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • The Rainer Arnhold Foundation

Registry information

Official study title

Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets

Acronym: IMPACT

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jul 17, 2012
Registry last updated
Jan 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.