Prevention Trial to Achieve Cardiovascular Targets (IMPACT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by New York University School of Medicine
Sponsor:
Collaborator:
The Rainer Arnhold Foundation
Information provided by (Responsible Party):
Eugenia Gianos, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01642355
First received: July 3, 2012
Last updated: September 23, 2014
Last verified: September 2014

July 3, 2012
September 23, 2014
June 2012
June 2015   (final data collection date for primary outcome measure)
Reduction of Non-HDL cholesterol [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01642355 on ClinicalTrials.gov Archive Site
  • Lipids [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    LDL-C, HDL, triglycerides
  • Metabolic risk factors [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    weight, BMI, HbA1C, abdominal circumference
  • Physical Activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Yale Physical Activity assessment (Part 2)
  • Nutrition [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Northwest Lipid Research Clinic (NWLRC) Fat Intake Score and fruit and vegetable assessment questions
  • Medication Adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Morisky-4 medication adherence survey
  • Optimal medical regimen [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    assessment of lipid lowering and cardiovascular medication regimen
  • Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Euro Qual 5D survey
  • Smoking cessation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Patient-based Assessment and Counseling for Physical Activity and Nutrition (PACE) smoking assessment
  • Cardiovascular risk [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    cardiovascular risk assessment score (i.e. Framingham)
  • Cardiovascular events [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    cardiovascular events and hospitalizations reported by phone call follow-up up to 5 years
  • Lipids [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    LCL-C, HDL triglycerides
  • Metabolic risk factors [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    weight, BMI, HbA1C, abdominal circumference
  • Physical Activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Yale Physical Activity assessment (Part 2)
  • Nutrition [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Northwest Lipid Research Clinic (NWLRC) Fat Intake Score and fruit and vegetable assessment questions
  • Medication Adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Morisky-4 medication adherence survey
  • Optimal medical regimen [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    assessment of lipid lowering and cardiovascular medication regimen
  • Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Euro Qual 5D survey
  • Smoking cessation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Patient-based Assessment and Counseling for Physical Activity and Nutrition (PACE) smoking assessment
  • Cardiovascular risk [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    cardiovascular risk assessment score (i.e. Framingham)
  • Cardiovascular events [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    cardiovascular events and hospitalizations reported by phone call follow-up up to 5 years
Not Provided
Not Provided
 
Prevention Trial to Achieve Cardiovascular Targets
Investigation of Motivational Interviewing and Prevention Consults 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 funded by a grant from the Rainer Arnhold Foundation and is scheduled to begin enrollment in the June of 2012.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Coronary Artery Disease
  • Peripheral Arterial Disease
  • Hyperlipidemia
  • Hypertension
  • Diabetes Mellitus/Prediabetes
  • Obesity
  • 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: Prevention Consults and 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.
  • 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
    Intervention: Behavioral: Prevention Consult
  • Active Comparator: Prevention Consult and Behavioral Intervention
    Intervention: Behavioral: Prevention Consults and Behavioral Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
June 2017
June 2015   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact: Michael Mushailov, B.A. 646-501-2666 Michael.Mushailov@nyumc.edu
Contact: Eugenia Gianos, M.D. 212 263-0855 eugenia.gianos@nyumc.org
United States
 
NCT01642355
IMPACT-2012-400
Yes
Eugenia Gianos, New York University School of Medicine
New York University School of Medicine
The Rainer Arnhold Foundation
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
New York University School of Medicine
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP