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Active Dectection of the Extension of Atherothrombosis in High Risk Coronary Patients (AMERICA)

This study is not yet open for participant recruitment.
Verified by Assistance Publique - Hôpitaux de Paris, March 2007

Sponsors and Collaborators: Assistance Publique - Hôpitaux de Paris
Institut de l'Atherothrombose
Information provided by: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00445835
  Purpose

Coronary artery disease is the first cause of death related to atherothrombosis. There is a close correlation between the extension of coronary artery disease and the severity of atherosclerotic lesions in extra coronary arterial beds. In addition, these symptomatic extracoronary lesions dramatically decrease the survival of these patients. However, scant data are available regarding the prevalence of extracoronary asymptomatic lesions. Conversely, the annual absolute risk of these lesions remains unknown. Consequently, whether a systematic identification of these extracoronary asymptomatic lesions is relevant remains to be established. The Primary Objective and Primary Endpoint of the AMERICA study is to demonstrate the superiority of an active detection and management of the extension of atherothrombosis in high Risk coronary patients (active strategy) in comparison with standard of care for coronary atherosclerosis (conservative strategy).


Condition Intervention
Coronary Artery Disease
Behavioral: arterial doppler for screening asymptomatic and significant extracoronary arterial stenoses in all arterial beds

MedlinePlus related topics:   Coronary Artery Disease   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Active Detection and Management of the Extension of Atherothrombosis in High Risk Coronary Patients In Comparison With Standard of Care for Coronary Atherosclerosis: The AMERICA Study

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • death (all cause) or any ischemic event leading to rehospitalisation or any evidence of organ failure.

Secondary Outcome Measures:
  • Incidence of each composite of the primary endpoint.

Estimated Enrollment:   526
Study Start Date:   April 2007
Estimated Study Completion Date:   May 2010

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion criteria:

  1. Three vessel disease recently identified recently (<1 month)
  2. Actue coronary syndromes in patients>75 years old (<1 month)

Exclusion criteria:

  1. Absence of significant coronary lesions
  2. Other causes of rise in the troponin level
  3. Patient<18 years old
  4. Pregnant women
  5. Patient without affiliation to National Social Security
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445835

Contacts
Contact: Jean-Philippe COLLET, MD PhD     +33 1 42 16 29 62 ext +33 1 42 16 29     jean-philippe.collet@psl.aphp.fr    

Show 19 study locations  Show 19 Study Locations

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut de l'Atherothrombose

Investigators
Principal Investigator:     Jean-Philippe COLLET, MD PhD     Assistance Publique - Hôpitaux de Paris    
  More Information


Study ID Numbers:   P060902, PHAO 2006
First Received:   March 8, 2007
Last Updated:   March 14, 2007
ClinicalTrials.gov Identifier:   NCT00445835
Health Authority:   France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
coronary artery disease  
myocardial infarction  
atherothrombosis  
atherosclerosis  

Study placed in the following topic categories:
Coronary Disease
Arterial Occlusive Diseases
Atherosclerosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia
Arteriosclerosis
Infarction
Myocardial Infarction
Coronary Artery Disease

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 31, 2008




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