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Status unknownNCT03538509PCI-HOPEUpdated May 30, 2018

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

An observational study in Heart Transplant Failure and Rejection and Coronary Artery Disease, sponsored by Fabrizio D'Ascenzo. Status unknown at 1 site in Italy. Per ClinicalTrials.gov, last updated 2018-05-30.

Sponsored by Fabrizio D'Ascenzo · Observational

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
150
Sex
All
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Study 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.

Read the 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 .

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Conditions studied

  • Heart Transplant Failure and Rejection
  • Coronary Artery Disease
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In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 150 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

This is the only study on the registry with Fabrizio D'Ascenzo as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Probability sample

Study population

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

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

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;
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Study design

Observational model
Case-only
Time perspective
Other
Enrollment
150 participants (estimated)
Target follow-up
18 Years
Patient registry
Yes

Interventions

  • OtherPCI and implantation drug eluting stent or bare metal stent

    Percutaneous Coronary Angioplasty

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What researchers measure

Primary outcomes

  1. Rate of restenosis

    observation rate of restenosis post-PCI

    Time frame: 18 years

Secondary outcomes

  1. MACE

    Number of Cardiovascular events

    Time frame: 18 years

  2. Rate of TCAD

    Number of CAD in transplant recipients

    Time frame: 18 years

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Study locations

1 of 1 sites recruiting
  • Citta della Salute
    Turin, 10128, Italy
    Recruiting
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References and documents

Publications

  • 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. PubMed 20398862 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03538509
Lead sponsor
Fabrizio D'Ascenzo
Collaborators
University of Zurich, Azienda Ospedaliera Universitaria Integrata Verona, University of Padova, University of Bologna, Hospital Clinic of Barcelona, University of Roma La Sapienza
Responsible party
Fabrizio D'Ascenzo (Medical Doctor, A.O.U. Città della Salute e della Scienza) — Sponsor-investigator
First posted
May 29, 2018
Start date
Jan 1, 2000
Primary completion
May 25, 2018
Completion
Oct 31, 2018 (estimated)
Last update
May 30, 2018

Study contacts

Fabrizio D'Ascenzo, MD
Contact
fabrizio.dascenzo@gmail.com
00390116336023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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