Coronary Artery DiseaseIMPACTNCT01642355
Prevention Trial to Achieve Cardiovascular Targets
A study testing Prevention Consult and Consult & Behavioral Intervention in people with Coronary Artery Disease and Peripheral Arterial Disease, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Coronary Artery Disease, Peripheral Arterial Disease, Hyperlipidemia
- What is being tested?
- Prevention Consult and Consult & Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Life expectancy less than 1-year
- Inability to walk
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University Langone Medical Center
New York, New York, 10016
About this study
Official title: Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets
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.
Read the 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.
- Conditions
- Coronary Artery Disease, Peripheral Arterial Disease, Hyperlipidemia, Hypertension, Diabetes, Prediabetes
- Being tested
- Prevention Consult, Consult & Behavioral Intervention
- Medical subject headings
- Coronary Artery Disease, Peripheral Arterial Disease, Hyperlipidemias, Hypertension, Diabetes Mellitus, Prediabetic State, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevention ConsultBehavioural
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 InterventionBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Prevention Consult |
| 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. Receives: Behavioral: Consult & Behavioral Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Non-HDL cholesterol
Measured: 6 months
Secondary outcomes (10)
Lipids
LDL-C, HDL, triglycerides
Measured: 6 months
Metabolic risk factors
weight, BMI, HbA1C, abdominal circumference
Measured: 6 months
Physical Activity
Yale Physical Activity assessment (Part 2)
Measured: 6 months
Nutrition
Northwest Lipid Research Clinic (NWLRC) Fat Intake Score and fruit and vegetable assessment questions
Measured: 6 months
Medication Adherence
Morisky-4 medication adherence survey
Measured: 6 months
Optimal medical regimen
assessment of lipid lowering and cardiovascular medication regimen
Measured: 6 months
Quality of life
Euro Qual 5D survey
Measured: 6 months
Smoking cessation
Patient-based Assessment and Counseling for Physical Activity and Nutrition (PACE) smoking assessment
Measured: 6 months
Cardiovascular risk
cardiovascular risk assessment score (i.e. Framingham)
Measured: 6 months
Cardiovascular events
cardiovascular events and hospitalizations reported by phone call follow-up up to 5 years
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- The Rainer Arnhold Foundation
- Responsible party
- Sponsor
- Investigators
- Eugenia Gianos, M.D., Principal investigator, NYU Langone HealthJeffrey S Berger, MD, MS, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642355
- Sponsor's protocol ID
- IMPACT-2012-400
- Acronym
- IMPACT
- Status last verified
- Dec 2016
- First submitted
- 3 Jul 2012
- Last updated
- 2 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 26385025Gianos 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.
PubMed 29754664
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets
- ClinicalTrials.gov ID
- NCT01642355
- Acronym / sponsor ID
- IMPACT / IMPACT-2012-400
- Conditions
- Coronary Artery Disease, Peripheral Arterial Disease, Hyperlipidemia, Hypertension, Diabetes, Prediabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- The Rainer Arnhold Foundation
- Study start
- Jun 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 17 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Prevention ConsultIn 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 | Behavioral: Consult & Behavioral InterventionIn 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. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Life expectancy less than 1-year
- Inability to walk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevention ConsultIn 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. | Behavioural | Prevention Consult |
| Consult & Behavioral InterventionIn 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. | Behavioural | Consult & Behavioral Intervention |
Primary outcome
Reduction of Non-HDL cholesterol
Time frame: 6 months
10 secondary outcomes
Lipids
Time frame: 6 months
Metabolic risk factors
Time frame: 6 months
Physical Activity
Time frame: 6 months
Nutrition
Time frame: 6 months
Medication Adherence
Time frame: 6 months
Optimal medical regimen
Time frame: 6 months
Quality of life
Time frame: 6 months
Smoking cessation
Time frame: 6 months
Cardiovascular risk
Time frame: 6 months
Cardiovascular events
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2017.
- Background: PubMed 26385025Gianos 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.
- Derived from this study: PubMed 29754664Gianos 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.
- New York University Langone Center for the Prevention of Cardiovascular Disease websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugenia Gianos, M.D. principal investigator
NYU Langone Health
Jeffrey S Berger, MD, MS principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevention Consult and Consult & Behavioral Intervention in people with Coronary Artery Disease and Peripheral Arterial Disease, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of Non-HDL cholesterol (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01642355, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2017.