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| Name | Class |
|---|---|
| The Rainer Arnhold Foundation | UNKNOWN |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | 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. | |
| Prevention Consult | Active Comparator | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevention Consult | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of Non-HDL cholesterol | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lipids | LDL-C, HDL, triglycerides | 6 months |
| Metabolic risk factors | weight, BMI, HbA1C, abdominal circumference | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugenia Gianos, M.D. | NYU Langone Health | Principal Investigator |
| Jeffrey S Berger, MD, MS | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University Langone Medical Center | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26385025 | Background | 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. | |
| 29754664 | Derived |
| Label | URL |
|---|---|
| New York University Langone Center for the Prevention of Cardiovascular Disease website | View source |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D058729 | Peripheral Arterial Disease |
| D006949 | Hyperlipidemias |
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| D011236 | Prediabetic State |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D011613 | Psychotherapy |
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|
| Consult & Behavioral Intervention | 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. |
|
| Physical Activity | Yale Physical Activity assessment (Part 2) | 6 months |
| Nutrition | Northwest Lipid Research Clinic (NWLRC) Fat Intake Score and fruit and vegetable assessment questions | 6 months |
| Medication Adherence | Morisky-4 medication adherence survey | 6 months |
| Optimal medical regimen | assessment of lipid lowering and cardiovascular medication regimen | 6 months |
| Quality of life | Euro Qual 5D survey | 6 months |
| Smoking cessation | Patient-based Assessment and Counseling for Physical Activity and Nutrition (PACE) smoking assessment | 6 months |
| Cardiovascular risk | cardiovascular risk assessment score (i.e. Framingham) | 6 months |
| Cardiovascular events | cardiovascular events and hospitalizations reported by phone call follow-up up to 5 years | 5 years |
| 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. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D050197 | Atherosclerosis |
| D016491 | Peripheral Vascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |