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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01642355
Other study ID # IMPACT-2012-400
Secondary ID
Status Completed
Phase N/A
First received July 3, 2012
Last updated December 30, 2016
Start date June 2012
Est. completion date May 2016

Study information

Verified date December 2016
Source New York University School of Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 21 Years to 99 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Intervention

Behavioral:
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.
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.

Locations

Country Name City State
United States New York University Langone Medical Center New York New York

Sponsors (2)

Lead Sponsor Collaborator
New York University School of Medicine The Rainer Arnhold Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

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