Percutaneous Coronary Intervention in Patients witH OrthotoPic hEart Transplantation: the PCI-HOPE a Multicenter Study.

NCT ID: NCT03538509

Last Updated: 2018-05-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2000-01-01
• Study Completion Date: 2018-10-31

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.

Detailed Description

Actual standard of care. Orthotopic heart transplantation (OHT) represents the optimal solution for the cure of end-stage heart failure, but it is burdened by numerous comorbidity. The main cause of morbidity and mortality in these patients is related to Transplant coronary artery disease (TCAD), that affects at least fifth percent of transplanted at five years of transplantation. TCAD is a purely immunological phenomen, emphasized by non-immunological factors, favoring oxidative stress, like dyslipidemia, smoking, hypertension, diabetes.(1-3) Many anatomic-pathological studies showed cellular infiltration with predominance of T-cell, mainly in the neointima and in adventizia. TCAD often resulted without angor because of denervation of the heart after transplantation (4-6). The managment and the treatment of TCAD are somewhat complex, because of accelerated vasal infiltration. Furthermore in multivessel disease a surgery revascularisation presented an elevated surgery risk.

Limits and complications of actual standard of care. In the first era of angioplasty percutaneous therapy was considered like palliation in this kind of coronary lesions , but with the beginning of BMS and DES era the outcomes of these patients considerably improved. However TCAD's lesions showed a rate of restenosis greater than classic atherosclerotic plaques(7). There is also a disagreement of results between implantation of DES or BMS, because some studies showed a superiority of the DES group, others didn't show any significant difference(8-9).

Potential improvements of standard of care. In this retrospective study an interesting point of research would be point out if the risk of restenosis was reduced with a particular kind of medicated stent for local effect of polymers, currently used. The general pharmacological effect of sirolimus was known like inhibitor of cell-T proliferation and then it could reduce vessel cellular infiltration, acting as a local immunosuppressant(10-12).

For this argument evidence is discordant, although the problem is getting relevant due to the prolonged survival of these patients and the augmented number of transplantation. These patients are often young and have an elevated general risk for iatrogenic immunosuppressed state. Therefore with this retrospective study we propose to understand the physio-pathological mechanisms of TCAD and also what actual therapy results the best .

Conditions

Heart Transplant Failure and Rejection; Coronary Artery Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Interventions

PCI and implantation drug eluting stent or bare metal stent

Percutaneous Coronary Angioplasty

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

1. Infective endocarditis;

2. Life expectancy less than 1 year for non-cardiovascular causes;

3. Recent cerebrovascular accident (<6 months);

4. Inability to express informed consent;

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: collaborator

Azienda Ospedaliera Universitaria Integrata Verona

OTHER

Sponsor Role: collaborator

University of Padova

OTHER

Sponsor Role: collaborator

University of Bologna

OTHER

Sponsor Role: collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role: collaborator

University of Roma La Sapienza

OTHER

Sponsor Role: collaborator

Fabrizio D'Ascenzo

OTHER

Sponsor Role: lead

Responsible Party

Fabrizio D'Ascenzo

Medical Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Citta della Salute

Turin, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Fabrizio D'Ascenzo, MD

Role: CONTACT

fabrizio.dascenzo@gmail.com

00390116336023

Facility Contacts

Fabrizio D'Ascenzo, MD

Role: primary

fabrizio.dascenzo@gmail.com

0116336023

References

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.

Reference Type: BACKGROUND

PMID: 20398862 (View on PubMed)

Other Identifiers

PCI-HOPE

Identifier Type: -

Identifier Source: org_study_id