Prevention Trial to Achieve Cardiovascular Targets (IMPACT)

This study has been completed.

Sponsor:

Collaborator:

The Rainer Arnhold Foundation

Information provided by (Responsible Party):

New York University School of Medicine

ClinicalTrials.gov Identifier:

NCT01642355

First received: July 3, 2012

Last updated: December 30, 2016

Last verified: December 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

July 3, 2012

Last Updated Date

December 30, 2016

Start Date ^ICMJE

June 2012

Primary Completion Date

May 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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

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 Provided

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

Enrollment ^ICMJE

400

Completion Date

May 2016

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

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

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