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

Coronary Artery Disease Clinical Trial

— PCI-HOPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03538509
• Other study ID #: PCI-HOPE
• Status: Recruiting
• Start date: January 1, 2000
• Est. completion date: October 31, 2018

Study information

• Verified date: May 2018
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: Fabrizio D'Ascenzo, MD
• Phone: 00390116336023
• Email: fabrizio.dascenzo[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 31, 2018
• Est. primary completion date: May 25, 2018
• Gender: All
• Age group: N/A and older

Eligibility

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;

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Transplant Failure and Rejection
• Myocardial Ischemia

Intervention

Other:
• PCI and implantation drug eluting stent or bare metal stent
Percutaneous Coronary Angioplasty

Locations

Country	Name	City	State
Italy	Citta della Salute	Turin

Sponsors (7)

Lead Sponsor	Collaborator
Fabrizio D'Ascenzo	Azienda Ospedaliera Universitaria Integrata Verona, Hospital Clinic of Barcelona, University of Bologna, University of Padova, University of Roma La Sapienza, University of Zurich

Country where clinical trial is conducted

Italy, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of restenosis	observation rate of restenosis post-PCI	18 years
Secondary	MACE	Number of Cardiovascular events	18 years
Secondary	Rate of TCAD	Number of CAD in transplant recipients	18 years