NCT03079791

Brief Summary

The aim of this study is to use the high resolution of optical coherence tomography to assess the prevalence of different types of cardiac allograft vasculopathy (CAV) in cardiac transplanted patients and correlate those results with the level of immunosuppression

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2016

Completed
8 months until next milestone

First Posted

Study publicly available on registry

March 14, 2017

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

6.5 years

First QC Date

July 27, 2016

Last Update Submit

May 8, 2023

Conditions

Transplant; Failure, Heart

Keywords

OCTcardiac allograft vasculopathyCAVintravascular imaging

Outcome Measures

Primary Outcomes (1)

  • CAV patterns

    Evaluation of CAV with optical coherence tomography imaging in different follow-up timepoints according to the Heart Transplant Care guidelines

    2 years

Secondary Outcomes (2)

  • Immunosuppression compliance

    2 years

  • combined ischemic events

    2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients after successful cardiac transplantation at the time of coronary angiography as part of routine follow-up after cardiac transplantation or as invasive diagnostic tool in case of clinical suspicion of cardiac allograft vasculopathy and indication for intravascular imaging according to guidelines.

You may qualify if:

  • Patients after cardiac transplantation undergoing planed routine angiographic examination and intracoronary imaging.
  • Written informed consent

You may not qualify if:

  • Age \< 18 years old
  • Hemodynamic and/or electric instability
  • Chronic kidney failure with glomerular filtration rate \< 30 ml/min
  • Pregnant or breastfeeding women
  • Incapacity of providing informed consent
  • If in the investigator's opinion the patient has (a) co-morbid condition(s) that could limit the patient's ability to participate in the study or impact the scientific integrity of the study
  • Any contraindication to intracoronary imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Munich University Hospital

Munich, Bavaria, 81377, Germany

Location

Study Officials

  • Steffen Massberg, MD

    LMU Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

July 27, 2016

First Posted

March 14, 2017

Study Start

July 1, 2016

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

May 9, 2023

Record last verified: 2023-05

Locations

DE(1)