Prevention Trial to Achieve Cardiovascular Targets (IMPACT)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified September 2014 by New York University School of Medicine
Sponsor:
New York University School of Medicine
Collaborator:
The Rainer Arnhold Foundation
Information provided by (Responsible Party):
Eugenia Gianos, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01642355
First received: July 3, 2012
Last updated: September 23, 2014
Last verified: September 2014
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 3, 2012 | ||||||||
| Last Updated Date | September 23, 2014 | ||||||||
| Start Date ICMJE | June 2012 | ||||||||
| Estimated Primary Completion Date | June 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Reduction of Non-HDL cholesterol [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||||||
| 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 |
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| Original Secondary Outcome Measures ICMJE |
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| 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 funded by a grant from the Rainer Arnhold Foundation and is scheduled to begin enrollment in the June of 2012. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 400 | ||||||||
| Estimated Completion Date | June 2017 | ||||||||
| Estimated Primary Completion Date | June 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 21 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
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| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01642355 | ||||||||
| Other Study ID Numbers ICMJE | IMPACT-2012-400 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Eugenia Gianos, New York University School of Medicine | ||||||||
| Study Sponsor ICMJE | New York University School of Medicine | ||||||||
| Collaborators ICMJE | The Rainer Arnhold Foundation | ||||||||
| Investigators ICMJE |
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| Information Provided By | New York University School of Medicine | ||||||||
| Verification Date | September 2014 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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