NCT03538509

Brief Summary

This is a retrospective, multicenter, study including patients undergone to one or more percutaneous revascularization after OHT. The rate of restenosis, the kind of percutaneous revascularization, the feature of coronary disease and the medical therapy for positive vessel remodeling will be evaluated.

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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

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

Study Start

First participant enrolled

January 1, 2000

Completed
18.4 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2018

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 29, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

18.4 years

First QC Date

May 16, 2018

Last Update Submit

May 25, 2018

Conditions

Heart Transplant Failure and RejectionCoronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Rate of restenosis

    observation rate of restenosis post-PCI

    18 years

Secondary Outcomes (2)

  • MACE

    18 years

  • Rate of TCAD

    18 years

Interventions

PCI and implantation drug eluting stent or bare metal stentOTHER

Percutaneous Coronary Angioplasty

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Evaluation incidence, prognostic factors and outcomes of percutaneous theraphy in patients with Transplant Coronary Artery Disease (TCAD)

You may qualify if:

  • All consecutive patients undergone percutaneous revascularization, both with symptomatic CAD and asymptomatic, with one or more coronary vessel disease, will be enrolled.

You may not qualify if:

  • Infective endocarditis;
  • Life expectancy less than 1 year for non-cardiovascular causes;
  • Recent cerebrovascular accident (\<6 months);
  • Inability to express informed consent;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Citta della Salute

Turin, 10128, Italy

RECRUITING

Related Publications (1)

  • Zimmer RJ, Lee MS. Transplant coronary artery disease. JACC Cardiovasc Interv. 2010 Apr;3(4):367-77. doi: 10.1016/j.jcin.2010.02.007.

    PMID: 20398862BACKGROUND

MeSH Terms

Conditions

Rejection, PsychologyCoronary Artery Disease

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Fabrizio D'Ascenzo, MD

CONTACT

00390116336023fabrizio.dascenzo@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
18 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

May 16, 2018

First Posted

May 29, 2018

Study Start

January 1, 2000

Primary Completion

May 25, 2018

Study Completion

October 31, 2018

Last Updated

May 30, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)