Clinical trial NCT01642355: Prevention Trial to Achieve Cardiovascular Targets
Official title: Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Peripheral Arterial Disease
Hyperlipidemia
Hypertension
Diabetes
Prediabetes
Obesity
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: The Rainer Arnhold Foundation
First posted: 2012-07-17
Enrollment: 400
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Reduction of Non-HDL cholesterol
timeFrame: 6 months
Secondary outcomes:
measure: Lipids
timeFrame: 6 months
measure: Metabolic risk factors
timeFrame: 6 months
measure: Physical Activity
timeFrame: 6 months
measure: Nutrition
timeFrame: 6 months
measure: Medication Adherence
timeFrame: 6 months
measure: Optimal medical regimen
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
measure: Smoking cessation
timeFrame: 6 months
measure: Cardiovascular risk
timeFrame: 6 months
measure: Cardiovascular events
timeFrame: 5 years
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Eugenia Gianos, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Health
name: Jeffrey S Berger, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.