Cardiac MRI and Cardiac Allograft Rejection

NCT04311346 | Unknown

• 1 other identifier: Helsinki UCH CMR
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

In this a prospective, blinded, collaboration study between pediatric and adult transplant departments. Cardiac MRI data on patient with heart transplantations will be collected during years 2020-2022. Based on sample size calculations, the data has enough power to answer the question, whether MRI can be used as a noninvasive diagnostic tool for detection of acute rejection as such or whether it can be used as fist line noninvasive screening tool for detecting those needing for the more detailed invasive study. A clinical protocol will be developed to optimize the management and outcome of the patients having cardiac transplantation aiming to decrease the number of invasive procedures in these patients.

Conditions

Rejection Heart Transplant

Keywords

CMR; cardiac rejection; cardiac transplatation

Outcome Measures

Primary Outcomes (8)

• Cardiac rejection

  Grade 0- Grade \>2

  Month 1

• Cardiac rejection

  Grade 0- Grade \>2

  Month 2

• Cardiac rejection

  Grade 0- Grade \>2

  Month 3

• Cardiac rejection

  Grade 0- Grade \>2

  Month 4

• Cardiac rejection

  Grade 0- Grade \>2

  Month 5

• Cardiac rejection

  Grade 0- Grade \>2

  Month 6

• Cardiac rejection

  Grade 0- Grade \>2

  Year 1

• Cardiac rejection

  Grade 0- Grade \>2

  Year 2

Study Arms (1)

Cardiac transplant

Patients exposed to cardiac transplantation

Diagnostic Test: Cardiac MR

Interventions

Cardiac MR DIAGNOSTIC_TEST

Cardiac MR diagnostic tool for detection of acute rejection, double blind comparison with invasive cardiac biopsy

Cardiac transplant

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All cardiac transplantations both in adults and in children have been centralized to Helsinki University Hospital, Finland. All patients both adults and children exposed to cardiac transplatations during the study period will be recruited to the study, if no contraindication for cardiac MR examination. Sample size calculation: the required total sample size is 72 patients

You may qualify if:

• Clinical diagnosis of Cardiac Transplantation
• Patient must be suitable for cardiac CMR imagnining

You may not qualify if:

• \- Patient has pace maker

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki University Central Hospital

Helsinki, 218, Finland

RECRUITING

Related Publications (1)

• Taipale MA, Pentikainen MO, Martelius LA, Mutka A, Kytola SI, Kankainen M, Peltonen JI, Syrjala SO, Lahtiharju AJI, Lommi JJ, Jahnukainen TJ, Lemstrom KB, Ojala TH. Cardiac magnetic resonance in heart transplant recipients: histological, clinical and cell-free DNA validation. Eur Heart J Cardiovasc Imaging. 2025 Jul 31;26(8):1420-1428. doi: 10.1093/ehjci/jeaf145.

  PMID: 40384031 DERIVED

Study Officials

• Tiina Ojala, MD, PhD

  Helsinki University Hospital, Finland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiina H Ojala, MD, PhD

CONTACT

+358504270558; tiina.h.ojala@hus.fi

Karl Lemström, Professor

CONTACT

+358504272281; karl.lemstrom@hus.fi

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 17, 2020
• Study Start: March 7, 2020
• Primary Completion: March 7, 2022
• Study Completion: March 7, 2024
• Last Updated: March 17, 2020

Record last verified: 2020-03

Locations

FI (1)