RecruitingNCT06656065

IMR-Heart Trasplant Study

Index Microvascular Resistance (IMR) in Heart Transplant Patients


Sponsor

Hospital Miguel Servet

Enrollment

100 participants

Start Date

May 23, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Heart transplant patients >18 years.
  • Patients who have received and signed informed consent.

Exclusion Criteria5

  • Patients with hemodynamic instability after HT, including cardiogenic shock or severe coagulopathy.
  • Patients with acute cellular rejection before intracoronary physiological assessment.
  • Patients with bronchial asthma or bronchopathy with a positive bronchodilation test, which contraindicates the use of adenosine.
  • Patients with epicardial coronary lesions with a resting physiological index ≤0.89 or ≤0.80 at hyperemia.
  • Patients unlikely to cooperate or with inability or unwillingness to give informed consent.

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Locations(2)

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Miguel Servet

Zaragoza, Zaragoza, Spain

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NCT06656065


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