NCT00484965

Brief Summary

The purpose of this study is to determine whether erythrocyte mediated dexamethasone delivery reduces circulating inflammatory markers after coronary stent implantation and improves clinical and angiographic outcomes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

1 active site

Status
unknown

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

June 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 12, 2007

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

June 12, 2007

Status Verified

June 1, 2007

First QC Date

June 11, 2007

Last Update Submit

June 11, 2007

Conditions

AtherosclerosisAcute-Phase Reaction

Keywords

Coronary stentInflammationAtherosclerosisImmunosuppressive

Outcome Measures

Primary Outcomes (1)

  • Determine whether erythrocyte mediated dexamethasone delivery reduces circulating inflammatory markers after coronary stent implantation and improves reduction of acute phase reaction proteins

    one year

Secondary Outcomes (1)

  • Reduction of myointimal proliferation and restenosis after stenting implantation

    one year

Interventions

Coronary stentingPROCEDURE

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • coronary disease
  • written informed consent
  • coronary stenosis
  • CRP baseline levels \< 0,5 mg/dl

You may not qualify if:

  • acute myocardial infarction
  • coronary bypass grafting restenosis
  • vessels diameter \< 2,5 mm
  • corticosteroids contraindications
  • corticosteroids therapy 30 days before
  • active infective disease
  • connective disease
  • pregnancy
  • cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Tor Vergata

Rome, 00133, Italy

Location

Related Publications (1)

  • Versaci F, Gaspardone A, Tomai F, Ribichini F, Russo P, Proietti I, Ghini AS, Ferrero V, Chiariello L, Gioffre PA, Romeo F, Crea F; Immunosuppressive Therapy for the Prevention of Restenosis after Coronary Artery Stent Implantation Study. Immunosuppressive Therapy for the Prevention of Restenosis after Coronary Artery Stent Implantation (IMPRESS Study). J Am Coll Cardiol. 2002 Dec 4;40(11):1935-42. doi: 10.1016/s0735-1097(02)02562-7.

    PMID: 12475452BACKGROUND

MeSH Terms

Conditions

AtherosclerosisAcute-Phase ReactionInflammation

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Francesco Versaci, MD, FACC

    Tor Vergata University, Rome

    PRINCIPAL INVESTIGATOR

  • Francesco Versaci, MD, FACC

    Tor Vergata University, Rome

    STUDY DIRECTOR

  • Luigi Chiariello, MD, FACC

    Tor Vergata University, Rome

    STUDY CHAIR

Central Study Contacts

Francesco Versaci, MD, FACC

CONTACT

+390620903536francescoversaci@yahoo.it

Costantino Del Giudice, MD

CONTACT

+390620903536costantino.delgiudice@yahoo.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 11, 2007

First Posted

June 12, 2007

Study Start

July 1, 2007

Study Completion

January 1, 2009

Last Updated

June 12, 2007

Record last verified: 2007-06

Locations

IT(1)