Depression Clinical Trial
Official title:
Microcirculatory Dysfunction in Stable Coronary Artery Disease: Relationship With Patient-focused Outcomes, Cerebral Small Vessel Disease and Depression.
This is a prospective cohort blinded study with the aim to investigate the prevalence and clinical impact of coronary microcirculatory dysfunction (CMD) in patients with ischemic heart disease, and its association with cerebral small vessel disease (CSVD) and depressive disorders. In addition, CMD and CSVD linkage to systemic inflammation and endothelial function will also be investigated.
The treatment of stable CAD is largely based on a paradigm that gives epicardial coronary
stenoses a central role in the generation of myocardial ischaemia. However, coronary
microcirculatory dysfunction (CMD) is a major and frequently ignored cause of ischaemia that,
according to retrospective studies, influences the outcomes of patients with CAD. In
addition, patients with CMD may not experience symptomatic relief with myocardial
revascularization or pharmacological treatment. This constitutes one of the causes of
persistent angina despite successful revascularization, causing not only an impairment of the
quality of life and higher consumption of healthcare resources, but potentially affective
disorders like depression, which has been found to be associated with CAD and with prognosis.
It also remains largely unknown whether CMD in stable CAD is organ-specific only or rather
indicative of involvement of other vital organs. While this seems to be the case in the
kidney and the retina, the relationship between CMD in the heart and the brain has not been
studied. Beyond classical cardiovascular risk factors linked to the development of ischemic
heart disease, systemic endothelial dysfunction could constitute a link between
microcirculatory involvement in both organs: the heart and the brain. Additionally, the
relation between chronic inflammatory status and microvascular disease in both the heart and
the brain is not known.
The principal hypotheses and sub-hypotheses are as follows:
Principal hypotheses: 1. Patients with CMD have worse prognosis compared to those ones with
normal coronary microcirculation. 2. Patients with CMD have a higher prevalence of CSVD. 3.
Chronic systemic inflammation status is an independent predictor of CMD and CSVD.
Sub-hypotheses: 1. The presence of CMD is associated to recurrent/persistent angina. 2. The
presence of CMD is associated to higher prevalence of depressive disorders. 3. CMD and CSVD
are associated to systemic endothelial dysfunction.
Primary Objectives associated to Principal hypotheses: 1. To investigate the relationship
between the presence of CMD and the development of patient-focused outcomes at 1 year of
follow-up. 2. To determine the prevalence of CSVD in patients with CAD with and without CMD.
3. To investigate the relationship between systemic inflammation and CMD.
Primary Objectives associated to Sub-hypotheses: 1. To determine the prevalence of persistent
or recurrent angina in patients with and without CMD in whom revascularization of CAD is
guided by FFR. 2. To determine the prevalence of depressive disorders in patients with and
without CMD. 3. To investigate the relationship between the status of systemic endothelial
function and the presence of CMD and CSVD.
Methods: Patients with CAD undergoing FFR-guided revascularisation will be prospectively
enrolled. FFR, coronary flow reserve (CFR) and the index of hyperemic microvascular
resistance (HMR) will be measured with the Doppler guidewire (Combowire, Volcano - Philips
corporation) under steady state hyperemia (intravenous adenosine infusion, 140 mcg/Kg/min).
CMD will be defined according to CFR and HMR, and will be used to classify the overall
population in two groups: the study group (presence of CMD) and the control group (absence of
CMD). Coronary revascularization will be decided according to result of FFR (cutoff ≤0.80).
After the procedure the patient will undergo baseline clinical assessment: • Neurological
clinical assessment and Transcranial Doppler Ultrasound. • Psychiatric clinical assessment. •
Stress Cardiac MRI and Cerebral MRI. • Peripheral endothelial function test with
plethysmography-based device EndoPat. • Laboratory blood tests for systemic inflammation
markers, platelet function and endothelial progenitor cells. • Baseline assessment of angina
status by the Seattle Questionnaire of angina (SAQ).
Clinical follow-up will be performed at 1-month, 6-months and 1-year, and will include: •
clinical cardiology and psychiatric assessment, assessment of angina status by the SAQ. •
stress test (1-year). • peripheral endothelial function test with plethysmography-based
device EndoPat (1-year). • neurological clinical assessment and Transcranial Doppler
Ultrasound (1- year). • laboratory blood tests for systemic inflammation markers, platelets
function and endothelial progenitor cells(1-year).
Type of blinding: Data regarding coronary microcirculation invasive assessment, neurologic
and psychiatric clinical assessment, cardiac and cerebral MRI, Trans-cranial Doppler
Ultrasound, laboratory blood tests, systemic endothelial function and follow-up will be
collected in a blinded fashion, so that patient and the other investigators, apart from the
invasive cardiology team responsible for patient enrollment and study coordination, could not
access to them. Primary events rate (major adverse cardiovascular events, incidence of CSVD,
systemic inflammation status, depressive disorders, recurrent angina and systemic endothelial
dysfunction) will be analyzed and correlated to CMD in a blinded fashion.
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