View Clinical Trial (Medical Research Study)
Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets
| City: |
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New York |
| State: |
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New York |
| Zip Code: |
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10016 |
| Conditions: |
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Coronary Artery Disease - Peripheral Arterial Disease - Hyperlipidemia - Hypertension - Diabetes Mellitus/Prediabetes - Obesity |
| Purpose: |
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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 funded by a grant
from the Rainer Arnhold Foundation and is scheduled to begin enrollment in the June of 2012.
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| Study Summary: |
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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.
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| 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:
- Subjects with a Non-HDL value of less than 100 mg/dl
- Life expectancy less than 1-year
- Inability to walk
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| NCT ID: |
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NCT01642355 |
| Primary Contact: |
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Principal Investigator
Eugenia Gianos, M.D.
New York University School of Medicine
Elizabeth Christopher, B.S.
Phone: 646-501-2666
Email: elizabeth.christopher@nyumc.edu
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| Backup Contact: |
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Email: eugenia.gianos@nyumc.org
Eugenia Gianos, M.D.
Phone: 212-263-7751
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| Location Contact: |
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New York, New York 10016
United States
Elizabeth Christopher, B.S.
Phone: 646-501-2666
Email: elizabeth.christopher@nyumc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
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