Prevention Trial to Achieve Cardiovascular Targets

NCT ID: NCT01642355

Last Updated: 2017-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-05-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease Peripheral Arterial Disease Hyperlipidemia Hypertension Diabetes Prediabetes Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Prevention Consult

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Consult & Behavioral Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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 Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Rainer Arnhold Foundation

UNKNOWN

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eugenia Gianos, M.D.

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Jeffrey S Berger, MD, MS

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University Langone Medical Center

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 26385025 (View on PubMed)

Gianos E, Schoenthaler A, Guo Y, Zhong J, Weintraub H, Schwartzbard A, Underberg J, Schloss M, Newman JD, Heffron S, Fisher EA, Berger JS. Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets (IMPACT) trial. Am Heart J. 2018 May;199:37-43. doi: 10.1016/j.ahj.2017.12.019. Epub 2018 Jan 9.

Reference Type DERIVED
PMID: 29754664 (View on PubMed)

Related Links

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http://www.med.nyu.edu/cvprevention/

New York University Langone Center for the Prevention of Cardiovascular Disease website

Other Identifiers

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IMPACT-2012-400

Identifier Type: -

Identifier Source: org_study_id

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