Prevention Trial to Achieve Cardiovascular Targets - Full Text View

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:

MedlinePlus related topics: Cholesterol Coronary Artery Disease Diabetes High Blood Pressure Obesity Peripheral Arterial Disease Pre-diabetes Quitting Smoking Smoking

U.S. FDA Resources

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

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

Contacts

Contact: Elizabeth Christopher, B.S.	646-501-2666	elizabeth.christopher@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: Elizabeth Christopher, B.S. 646-501-2666 elizabeth.christopher@nyumc.edu

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:

Related Info This link exits the ClinicalTrials.gov site

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:	March 1, 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 May 21, 2013

Prevention Trial to Achieve Cardiovascular Targets (IMPACT)