Status:
UNKNOWN
The Cerebral-Coronary Connection (C3) Study
Lead Sponsor:
Instituto de Salud Carlos III
Collaborating Sponsors:
Hospital San Carlos, Madrid
Conditions:
Ischemic Heart Disease
Microvascular Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
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 it...
Detailed Description
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 dysfunct...
Eligibility Criteria
Inclusion
- Informed Consent available.
- Age ≥ 18 years.
- Stable coronary lesions.
- Indication to FFR: ≥ 1 intermediate coronary lesion (40-80% diameter stenosis) in a principal/secondary vessel with ≥ 2 mm reference diameter.
Exclusion
- Previous myocardial infarction in the territory of distribution of the target vessel.
- Coronary Left Main severe stenosis.
- Aortic valve stenosis (moderate or severe) .
- Severe left ventricle hypertrophy.
- Left ventricle moderate systolic dysfunction (EF \< 35%).
- Contraindications to adenosine.
- Previous CABG with permeable grafts.
- Contraindication to stent implantation.
- Severe anemia.
- Coagulopathies or chronic anticoagulation.
- Platelets \< 75000 o \> 700.000.
- Previous stroke or intracranial hemorrhage.
- Contraindication to MRI.
- Chronic Renal Failure contraindicating gadolinium infusion during MRI: eGFR \< 60 ml/min), hemodialysis, previous renal transplantation.
- Pacemaker/ Implantable Cardioverter Device with contraindication to MRI.
- Planned cardiac surgery.
- Life expectancy \< 2 years.
Key Trial Info
Start Date :
March 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04131075
Start Date
March 1 2017
End Date
March 31 2020
Last Update
January 6 2020
Active Locations (1)
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1
Hospital Clínico San Carlos
Madrid, Spain, 28040