Actively Recruiting
IMR-Heart Trasplant Study
Led by Hospital Miguel Servet · Updated on 2025-11-21
100
Participants Needed
2
Research Sites
281 weeks
Total Duration
On this page
Sponsors
H
Hospital Miguel Servet
Lead Sponsor
C
Central University Hospital of Asturias
Collaborating Sponsor
AI-Summary
What this Trial Is About
Acute allograft rejection (AAR) is an important cause of morbi-mortality in heart transplant (HT) patients, particularly during the first year. Endomyocardial biopsy (EMB) is the "gold standard" to guide post- heart transplantation treatment. However, it is associated with complications that can be potentially serious. The index of microvascular resistance (IMR) is a specific physiological parameter used to assess microvascular function. Invasive coronary assessment has been shown to be both feasible and safe. Detection of coronary microvascular dysfunction (MCD) by IMR may help to identify high risk HT patients. In fact, an increased IMR measured early after HT has been associated with AAR, higher all-cause mortality and adverse cardiac events. A high IMR value early after HT may identify patients at higher risk who require increased surveillance or adjustments in immunosuppressive therapy. Conversely, a low IMR value may support reducing the number of EMBs. Our aim is to evaluate IMR in heart transplant patients within the first year. Changes in management after knowing IMR values and prognostic implications of IMR in a long term follow up will also be assessed.
CONDITIONS
Official Title
IMR-Heart Trasplant Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Heart transplant patients over 18 years old
- Patients who have received and signed informed consent
You will not qualify if you...
- Patients with hemodynamic instability after heart transplant, including cardiogenic shock or severe coagulopathy
- Patients with acute cellular rejection before coronary physiological assessment
- Patients with bronchial asthma or bronchopathy with a positive bronchodilation test that prevents use of adenosine
- Patients with epicardial coronary artery lesions causing low resting or hyperemic blood flow index
- Patients unlikely to cooperate or unable or unwilling to give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Active, Not Recruiting
2
Hospital Miguel Servet
Zaragoza, Zaragoza, Spain, 50009
Actively Recruiting
Research Team
G
Georgina Fuertes, MD PHD
CONTACT
A
Ainhoa Perez Guerrero, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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