NCT00725868

Brief Summary

In stent restenosis and myocardial infarction are have been linked the balance between injury and healing of the endothelium These processes can be measured respectively using the number of circulating endothelial cells and endothelial progenitor cells. We therefore aimed to evaluate the relationship between the balance of injury and healing of the endothelium at the time of PCI and major adverse cardiovascular events including death, myocardial infarction and target lesion revascularization at 6 and 12 months follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

September 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

May 7, 2026

Status Verified

August 1, 2011

Enrollment Period

2.9 years

First QC Date

July 30, 2008

Last Update Submit

May 4, 2026

Conditions

AtherosclerosisPercutaneous Coronary InterventionCardiovascular Diseases

Keywords

Major adverse

Outcome Measures

Primary Outcomes (1)

  • The main objective of this study is to estimate if the measure of CEC and PEC possesses a meaning forecast towards the arisen of complications post procedure.

    36 months

Secondary Outcomes (1)

  • To determine the relation between these endothelial biomarkers and the other usual parameters forecast complications post-angioplasty

    36 months

Study Arms (1)

1

OTHER

Data private hospitals, angioplasty, sampling of blood

Other: Data private hospitals, angioplasty, sampling of blood

Interventions

Data private hospitals, angioplasty, sampling of bloodOTHER

* Data private hospitals : Age, sex, index of body mass, factors of cardiovascular risk, medical surgical histories, treatment before and after the angioplasty, the renal insufficiency * coronary angioplasty * Sampling of blood : Before the angioplasty, 6 hours after the angioplasty and 24 hours after the angioplasty. A numeration of the proparents circulants (hématopoietics, PEC) and a numeration of CEC are made

1

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age\>18 years old
  • Scheduled for PCI
  • Clinical evidence of ischemic heart disease and/or abnormal functional study
  • New coronary artery lesion \>50%
  • treatment with bare metal stent planned
  • Informed consent explained, red, understood and signed by the patient

You may not qualify if:

  • Pregnancy, birth or lactation period \<6 months ago
  • Women of childbearing age who do not intend to use accepted anticonceptive measures or who wish to get pregnant
  • Left ventricular ejection fraction \<30%
  • Acute coronary syndrome (ST-elevation or not) in the past month
  • Planned drug eluting stent implantation
  • Lesion in arterial or venous bypass or anastomosis with coronary
  • Severe renal insufficiency (creatinine clearance \<30 mL/')
  • Severe hepatic insufficiency
  • Systemic inflammatory pathology of any kind
  • Hematologic or other malignancy, prior radio- or chemotherapy
  • Use of corticosteroïds or immune suppression therapy
  • Contrast allergy
  • Life expectancy \<1 year
  • Participation in other clinical study which has not ended yet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Cardiologie- Hopital Nord

Marseille, 13015, France

Location

Related Publications (1)

  • Bonello L, Harhouri K, Sabatier F, Camoin-Jau L, Arnaud L, Baumstarck-Barrau K, Ait-Mokhtar O, Roubille F, Piot C, Lesavre N, Paganelli F, Dignat-George F. Level of adenosine diphosphate receptor P2Y12 blockade during percutaneous coronary intervention predicts the extent of endothelial injury, assessed by circulating endothelial cell measurement. J Am Coll Cardiol. 2010 Sep 21;56(13):1024-31. doi: 10.1016/j.jacc.2010.01.072.

    PMID: 20846600RESULT

MeSH Terms

Conditions

AtherosclerosisCardiovascular Diseases

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

CatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Officials

  • Franck PAGANELLI, MD

    Assistance Publique des Hopitaux de Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2008

First Posted

July 31, 2008

Study Start

September 1, 2007

Primary Completion

August 1, 2010

Study Completion

December 1, 2010

Last Updated

May 7, 2026

Record last verified: 2011-08

Locations

FR(1)