NCT00430820

Brief Summary

The study hypothesis is that differential proteomic techniques can be used to discover new circulating biomarkers of coronary atherosclerosis in the blood of patients suffering from coronary artery disease (either stable or unstable) who will be compared to a group of patients without coronary artery disease

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2007

Completed
27 days until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

December 3, 2010

Status Verified

April 1, 2009

Enrollment Period

2.3 years

First QC Date

February 1, 2007

Last Update Submit

December 2, 2010

Conditions

Keywords

BiomarkersProteomicsMass spectrometryAtherosclerosisAcute coronary syndromesMyocardial infarctionCoronary artery disease

Study Arms (3)

1

30 patients

Procedure: per intervention

2

30 patients

Procedure: per intervention

3

30 patients

Procedure: per intervention

Interventions

per intervention

123

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Identification de nouveaux marqueurs circulants de l'athérosclérose coronarienne et de ses complications par une nouvelle technique de protéomique différentielle. Identification of new parqueurs circulated in coronary artheriosclerosis and complications of the new differentiel technicology

You may qualify if:

  • Group 1 (Non-ST-elevation acute myocardial infarction) :
  • Chest pain less than 48 hours before admission,
  • And modifications of ST-T (no persistent ST elevation) on 12-lead EKG,
  • And elevation of troponin-I \>1xN,
  • And presence of ≥1 de novo stenosis(es) \>50% located on ≥1 native coronary artery(ies) and successfully treated using percutaneous coronary intervention and stenting.
  • Group 2 (Stable coronary artery disease) :
  • Documented myocardial ischemia (stable angina or positive stress test)
  • And presence of ≥1 de novo stenosis(es) \>50% located on ≥1 native coronary artery(ies) and successfully treated using percutaneous coronary intervention and stenting.
  • Group 3 (Normal coronary arteries) :
  • No history of coronary artery disease, neurovascular disease or peripheral artery disease,
  • And normal coronary angiography performed because of suspected coronary artery disease
  • And absence of significant functional or anatomic abnormalities suggestive of atherosclerosis on non-invasive arterial studies (measurements of intima-media thickness, pulse wave velocity, ankle-brachial index, …).

You may not qualify if:

  • Group 1 :
  • Preexisting EKG abnormalities (including left bundle branch block) precluding accurate assessment of ST-T changes
  • Group 2 :
  • History of acute coronary syndrome
  • Groups 1 and 2:
  • Culprit coronary artery stenosis is a restenosis or a stent thrombosis or is located in a bypass graft.
  • All groups :
  • Heart failure (NYHA class ≥II)
  • Left ventricular ejection fraction \<50%
  • Severe valvular heart disease requiring surgical or percutaneous therapy
  • History of autoimmune, inflammatory or neoplasia diseases ; or infectious disease in the month before admission
  • Life expectancy \< 1 year
  • Age \<18 years or \>80 years
  • Current pregnancy or breast-feeding
  • Homeless or travelers who may not be followed-up
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Hopital Bichat, APHP

Paris, 75018, France

Location

Related Publications (5)

  • Duran MC, Mas S, Martin-Ventura JL, Meilhac O, Michel JB, Gallego-Delgado J, Lazaro A, Tunon J, Egido J, Vivanco F. Proteomic analysis of human vessels: application to atherosclerotic plaques. Proteomics. 2003 Jun;3(6):973-8. doi: 10.1002/pmic.200300389.

  • Martin-Ventura JL, Duran MC, Blanco-Colio LM, Meilhac O, Leclercq A, Michel JB, Jensen ON, Hernandez-Merida S, Tunon J, Vivanco F, Egido J. Identification by a differential proteomic approach of heat shock protein 27 as a potential marker of atherosclerosis. Circulation. 2004 Oct 12;110(15):2216-9. doi: 10.1161/01.CIR.0000136814.87170.B1. Epub 2004 Jul 12.

  • Vivanco F, Martin-Ventura JL, Duran MC, Barderas MG, Blanco-Colio L, Darde VM, Mas S, Meilhac O, Michel JB, Tunon J, Egido J. Quest for novel cardiovascular biomarkers by proteomic analysis. J Proteome Res. 2005 Jul-Aug;4(4):1181-91. doi: 10.1021/pr0500197.

  • Blanco-Colio LM, Martin-Ventura JL, Vivanco F, Michel JB, Meilhac O, Egido J. Biology of atherosclerotic plaques: what we are learning from proteomic analysis. Cardiovasc Res. 2006 Oct 1;72(1):18-29. doi: 10.1016/j.cardiores.2006.05.017. Epub 2006 May 24.

  • Ramos-Mozo P, Madrigal-Matute J, Vega de Ceniga M, Blanco-Colio LM, Meilhac O, Feldman L, Michel JB, Clancy P, Golledge J, Norman PE, Egido J, Martin-Ventura JL. Increased plasma levels of NGAL, a marker of neutrophil activation, in patients with abdominal aortic aneurysm. Atherosclerosis. 2012 Feb;220(2):552-6. doi: 10.1016/j.atherosclerosis.2011.11.023. Epub 2011 Nov 25.

Biospecimen

Retention: SAMPLES WITH DNA

biomarqueurs

MeSH Terms

Conditions

Coronary Artery DiseaseAcute Coronary SyndromeMyocardial InfarctionAtherosclerosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Laurent FELDMAN, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 1, 2007

First Posted

February 2, 2007

Study Start

March 1, 2007

Primary Completion

July 1, 2009

Study Completion

November 1, 2009

Last Updated

December 3, 2010

Record last verified: 2009-04

Locations