Early Detection of Atherosclerosis: a Randomized Trial in the Primary Prevention of Cardiovascular Diseases. (PRIMARIA)
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ClinicalTrials.gov Identifier: NCT00734123 |
Recruitment Status : Unknown
Verified August 2008 by Hospital Arnau de Vilanova.
Recruitment status was: Recruiting
First Posted : August 14, 2008
Last Update Posted : August 14, 2008
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Sponsor:
Hospital Arnau de Vilanova
Collaborator:
Pfizer
Information provided by:
Hospital Arnau de Vilanova
Tracking Information | ||||
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First Submitted Date ICMJE | August 11, 2008 | |||
First Posted Date ICMJE | August 14, 2008 | |||
Last Update Posted Date | August 14, 2008 | |||
Study Start Date ICMJE | April 2008 | |||
Estimated Primary Completion Date | April 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Carotid Intima-Media Thickness progression/regression [ Time Frame: 2 years ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE |
Cardio and cerebrovascular eventS [ Time Frame: 5 years ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Early Detection of Atherosclerosis: a Randomized Trial in the Primary Prevention of Cardiovascular Diseases. | |||
Official Title ICMJE | Early Detection of Atherosclerosis in the Primary Care Setting: a Randomized Trial to Assess the Efficacy of a Novel Strategy in the Primary Prevention of Cardiovascular Diseases. | |||
Brief Summary | The incidence of cardiovascular diseases is still high and further efforts should be done in primary prevention. The main objective is to quantify the burden of subclinical atherosclerosis using non-invasive techniques,and to study the impact of this assessment and consequent treatment in the progression of atherosclerosis and in the incidence of cardiovascular diseases. | |||
Detailed Description | We will perform non-invasive techniques (carotid Intima-Media Thickness, CAC score and ankle-brachial index) to individuals at intermediate cardiovascular risk.With these results, we will classify participants in: no atherosclerosis, mild, moderate and severe atherosclerosis, and therapeutic targets will be set according to pre-defined algorithms. The end-point will be the course of atherosclerosis measured by cIMT/CAC score (2 years) and the incidence of CVD at 5 years of follow-up. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* 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 | Unknown status | |||
Estimated Enrollment ICMJE |
2948 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date ICMJE | May 2013 | |||
Estimated Primary Completion Date | April 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria One or more of the following:
The presence of two or more of the following:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 40 Years to 74 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Spain | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00734123 | |||
Other Study ID Numbers ICMJE | UDETMA_08 UDETMA_2008_001 |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Elvira Fernandez, Hospital Arnau de Vilanova | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Hospital Arnau de Vilanova | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | Hospital Arnau de Vilanova | |||
Verification Date | August 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |