Early Detection of Atherosclerosis: a Randomized Trial in the Primary Prevention of Cardiovascular Diseases.
NCT00734123
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
+34 619633249
One or more of the following:
- Familiar History of early-onset cardiovascular disease (male < 55 or female < 65).
- Type 2 Diabetes mellitus or type 1 with microalbuminuria.
- Essential High Blood Pressure.
- Chronic Kidney Disease.
- Primary hyperlipidemia.
The presence of two or more of the following:
- Current smoker.
- Physical inactivity.
- High blood pressure (recently diagnosed).
- Abdominal perimeter: > 102 cm. males; > 88 cm. females.
- Total cholesterol > 240 mg/dL.
- HDL cholesterol ≤ 40 mg/dL males, ≤ 50 mg/dL females.
- Age < 40 or > 74 years old.
- Previous Cardiovascular Event.
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Descriptive Information | ||||
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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 | |||
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. | ||||
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 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Elvira Fernandez, Hospital Arnau de Vilanova | |||
Study Sponsor ICMJE | Hospital Arnau de Vilanova | |||
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 |