mCAV: Microvascular Cardiac Allograft Vasculopathy Trial
Study Details
Study Description
Brief Summary
The aim of the mCAV study is a comprehensive characterization of the genetic, morphological and functional phenotype of isolated microvascular graft vasculopathy (mCAV) after orthotopic heart transplantation (OHT).
The utilized methods include dynamic echocardiography, magnetic resonance imaging, invasive microvascular resistance measurements, histology, cellular calcium-signaling and magnetocardiography as well as molecular genetic expression analysis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| microvascular cardiac allograft vasculopathy Heart transplant recipients with microvascular cardiac allograft vasculopathy defined by histopathology and invasive index of microvascular resistance. |
Diagnostic Test: Echocardiography
Echocardiography with afterload change
Diagnostic Test: Magnetic resonance imaging
Stress-MRI
Diagnostic Test: Magnetocardiography
Magnetocardiography
Diagnostic Test: Histology
Histological analysis
Diagnostic Test: Genetics
miRNA sequencing
Diagnostic Test: calcium signaling
cardiomyocyte calcium signaling
Diagnostic Test: IMR
Index of microvascular resistance measurement
Diagnostic Test: Angio-IMR
Angiography derived post-processing index if microvascular resistance
|
| control Heart transplant recipients without microvascular cardiac allograft vasculopathy defined by histopathology and invasive index of microvascular resistance. |
Diagnostic Test: Echocardiography
Echocardiography with afterload change
Diagnostic Test: Magnetic resonance imaging
Stress-MRI
Diagnostic Test: Magnetocardiography
Magnetocardiography
Diagnostic Test: Histology
Histological analysis
Diagnostic Test: Genetics
miRNA sequencing
Diagnostic Test: calcium signaling
cardiomyocyte calcium signaling
Diagnostic Test: IMR
Index of microvascular resistance measurement
Diagnostic Test: Angio-IMR
Angiography derived post-processing index if microvascular resistance
|
Outcome Measures
Primary Outcome Measures
- mCAV status influences pw-doppler wall motion analysis in echocardiography [at study inclusion]
pw-doppler wall motion analysis is measured with afterload increase
- mCAV status influences global longitudinal strain in echocardiography [at study inclusion]
global longitudinal strain is measured by speckle tracking analysis with afterload increase
- mCAV status influences diastolic strain in echocardiography [at study inclusion]
diastolic strain is measured by speckle tracking analysis with afterload increase
- mCAV status influences cardiac deformity [at study inclusion]
cardiac deformity analysis are performed by MRI
- mCAV status influences grade of fibrosis [at study inclusion]
fibrosis grades are measured by MRI
- mCAV status influences extracellular volume [at study inclusion]
extracellular volume is measured by MRI
- mCAV status influences the circulating miRNA profile [at study inclusion]
circulating miRNA profile is measured by miRNAseq
Secondary Outcome Measures
- mCAV status influences the intrinsic cardiac magnetic field [at study inclusion]
the intrinsic cardiac magnetic field is measured by magnetocardiography
- mCAV status influences the cellular calcium signaling [at study inclusion]
the cellular calcium is visualized by confocal laser microscopy using electrical stimulation
- mCAV status influences subcellular structures [at study inclusion]
mitochondria, T-tubuli are described after visualization by confocal laser microscopy
Eligibility Criteria
Criteria
Inclusion Criteria:
-
able to consent
-
Written consent of the participant after clarification and sufficient time to think about participation
-
heart transplant recipient
-
Indication for routine invasive diagnostics or due to symptoms
-
Exercise tolerant in everyday life - cycling, climbing stairs at least 2 floors at a moderate speed without symptoms of exertion or dyspnea
Exclusion Criteria:
-
Addiction or other diseases that do not allow the patient to assess the nature and scope as well as possible consequences of the study
-
Patients or their legal guardians who do not sign the declaration of consent or who cannot fully understand it due to a lack of German language skills
-
Pregnant women, breastfeeding women
-
Severe comorbidities affecting the miRNA profile: diabetes mellitus, malignancy, end-stage renal disease with renal replacement therapy
-
Contraindication to the stress test: signs of cardiac decompensation, angina pectoris, dyspnea, hyperthyroidism, GFR <30 ml/min, peripheral arterial disease, pheochromocytoma, angle-closure glaucoma, prostate adenoma, paroxysmal tachycardia, tachycardia atrial fibrillation
-
Evidence of an acute rejection or local wall motion disturbances in the resting echocardiography
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | DHZC Deutsches Herzzentrum der Charité | Berlin | Germany | 13353 |
Sponsors and Collaborators
- German Heart Institute
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Deutsche Stiftung für Herzforschung
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- mCAV