Prevention Trial to Achieve Cardiovascular Targets (IMPACT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 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: November 8, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Peripheral Arterial Disease
Hyperlipidemia
Hypertension
Diabetes Mellitus/Prediabetes
Obesity
Behavioral: Prevention Consult
Behavioral: Prevention Consults and Behavioral Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Reduction of Non-HDL cholesterol [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 400
Study Start Date: June 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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.
Active Comparator: Prevention Consult and Behavioral Intervention 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.

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • Subjects with a Non-HDL value of less than 100 mg/dl
  • Life expectancy less than 1-year
  • Inability to walk
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642355

Contacts
Contact: Michael Mushailov, B.A. 646-501-2666 Michael.Mushailov@nyumc.edu
Contact: Eugenia Gianos, M.D. 212-263-7751 eugenia.gianos@nyumc.org

Locations
United States, New York
New York Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Michael Mushailov, B.A.    646-501-2666    michael.mushailov@nyumc.org   
Sponsors and Collaborators
New York University School of Medicine
The Rainer Arnhold Foundation
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Eugenia Gianos, Assistant Professor; Department of Medicine, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01642355     History of Changes
Other Study ID Numbers: IMPACT-2012-400
Study First Received: July 3, 2012
Last Updated: November 8, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Hyperlipidemias
Hypertension
Obesity
Peripheral Arterial Disease
Peripheral Vascular Diseases
Glucose Intolerance
Prediabetic State
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dyslipidemias
Lipid Metabolism Disorders
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Atherosclerosis
Hyperglycemia

ClinicalTrials.gov processed this record on July 26, 2014