Prevention Trial to Achieve Cardiovascular Targets (IMPACT)

Tracking Information
First Submitted Date ICMJE	July 3, 2012
First Posted Date ICMJE	July 17, 2012
Last Update Posted Date	January 2, 2017
Study Start Date ICMJE	June 2012
Actual Primary Completion Date	May 2016 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: July 14, 2012)	Reduction of Non-HDL cholesterol [ Time Frame: 6 months ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01642355 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 23, 2014)	Lipids [ Time Frame: 6 months ]LDL-C, HDL, triglycerides; Metabolic risk factors [ Time Frame: 6 months ]weight, BMI, HbA1C, abdominal circumference; Physical Activity [ Time Frame: 6 months ]Yale Physical Activity assessment (Part 2); Nutrition [ Time Frame: 6 months ]Northwest Lipid Research Clinic (NWLRC) Fat Intake Score and fruit and vegetable assessment questions; Medication Adherence [ Time Frame: 6 months ]Morisky-4 medication adherence survey; Optimal medical regimen [ Time Frame: 6 months ]assessment of lipid lowering and cardiovascular medication regimen; Quality of life [ Time Frame: 6 months ]Euro Qual 5D survey; Smoking cessation [ Time Frame: 6 months ]Patient-based Assessment and Counseling for Physical Activity and Nutrition (PACE) smoking assessment; Cardiovascular risk [ Time Frame: 6 months ]cardiovascular risk assessment score (i.e. Framingham); Cardiovascular events [ Time Frame: 5 years ]cardiovascular events and hospitalizations reported by phone call follow-up up to 5 years
Original Secondary Outcome Measures ICMJE; (submitted: July 14, 2012)	Lipids [ Time Frame: 6 months ]LCL-C, HDL triglycerides; Metabolic risk factors [ Time Frame: 6 months ]weight, BMI, HbA1C, abdominal circumference; Physical Activity [ Time Frame: 6 months ]Yale Physical Activity assessment (Part 2); Nutrition [ Time Frame: 6 months ]Northwest Lipid Research Clinic (NWLRC) Fat Intake Score and fruit and vegetable assessment questions; Medication Adherence [ Time Frame: 6 months ]Morisky-4 medication adherence survey; Optimal medical regimen [ Time Frame: 6 months ]assessment of lipid lowering and cardiovascular medication regimen; Quality of life [ Time Frame: 6 months ]Euro Qual 5D survey; Smoking cessation [ Time Frame: 6 months ]Patient-based Assessment and Counseling for Physical Activity and Nutrition (PACE) smoking assessment; Cardiovascular risk [ Time Frame: 6 months ]cardiovascular risk assessment score (i.e. Framingham); Cardiovascular events [ Time Frame: 5 years ]cardiovascular events and hospitalizations reported by phone call follow-up up to 5 years
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Prevention Trial to Achieve Cardiovascular Targets
Official Title ICMJE	Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets
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 Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention
Condition ICMJE	Coronary Artery Disease; Peripheral Arterial Disease; Hyperlipidemia; Hypertension; Diabetes; Prediabetes; Obesity
Intervention ICMJE	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.; Behavioral: 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.
Study Arms	No Intervention: Usual Care 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.; Active Comparator: 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. Intervention: Behavioral: Prevention Consult; Active Comparator: 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. Intervention: Behavioral: Consult & Behavioral Intervention
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: July 14, 2012)	400
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	May 2016
Actual Primary Completion Date	May 2016 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	21 Years to 99 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01642355
Other Study ID Numbers ICMJE	IMPACT-2012-400
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	New York University School of Medicine
Study Sponsor ICMJE	New York University School of Medicine
Collaborators ICMJE	The Rainer Arnhold Foundation
Investigators ICMJE	Principal Investigator: Eugenia Gianos, M.D. New York University School of Medicine Principal Investigator: Jeffrey S Berger, MD, MS New York University School of Medicine
PRS Account	New York University School of Medicine
Verification Date	December 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP