Health TrialsbyHealthPanel

Physiologic Assessment of Microvascular Function in Heart Transplant Patients

ConditionCardiac Allograft Vasculopathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorSamsung Medical Center

About this trial

The aim of the study is to evaluate the impact of early microvascular disease assessed by coronary physiologic indices such as fractional flow reserve (FFR), coronary flow reserve (CFR), index of microvascular resistance (IMR) on future occurrence of cardiac allograft vasculopathy (CAV) in heart transplant recipients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject over age of 18

Patients received heart transplant

Disqualifiers

Patients with cardiogenic shock

Patients with unstable vital sign that precludes coronary angiography

Patients with major bleeding in last 3 months

Patients with active bleeding

Trial population

Consecutive patients who received heart transplant undergoing coronary angiography for evaluation of coronary disease

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Rates of cardiac death between patients with or without overt microvascular disease (CFR≤2 and IMR≥25) diagnosed with physiologic evaluation at 2-year follow-up after heart transplantation

Time frame
72 months
2

Acute cellular rejection between patients with or without overt microvascular disease

Time frame
72 months

Secondary outcomes

1

Occurrence of anatomically significant cardiac allograft vasculopathy (% diameter stenosis > 50% on CCTA)

Time frame
72 months
2

Comparison of total aggregated plaque volume and presence of adverse plaque characteristics on CCTA between transplant patients with or without overt microvascular disease (CFR≤2 and IMR≥25).

Time frame
72 months
3

Comparison of all-cause mortality in transplant patients with or without overt microvascular disease (CFR≤2 and IMR≥25) diagnosed with physiologic evaluation at 2-year follow-up after heart transplantation.

Time frame
24 months
4

Comparison of rates of cardiac death in transplant patients with or without overt microvascular disease (CFR≤2 and IMR≥25) diagnosed with physiologic evaluation at 1-year follow-up after heart transplantation.

Time frame
72 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Samsung Medical Center

Lead sponsor

Source ClinicalTrials.gov
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