Selected Clinical Studies
The PESA-CNIC-Santander study is a long-term endeavor carried out by the CNIC in collaboration with Santander Bank. This study aims to identify the presence of atherosclerosis long before symptoms
appear and to understand the cues leading to its development and progression. The study, led by CNIC General Director Valentin Fuster, launched in 2010 and enrolled 4200 asymptomatic individuals between the ages of 40 and 55. Participants
undergo serial (every 3 years) imaging and analytical tests, including 3D vascular ultrasound of the carotid arteries, aorta, and iliofemoral arteries to detect atherosclerotic plaques, coronary artery calcium quantification by
computed tomography, and biosampling for omics analysis. A subset of 800 participants showing signs of disease are undergoing vascular 18FDG PET/MR and cardiac MR. In 2019, the third (6-year) visit will be completed for the full
cohort. Several CNIC clinical and basic research groups participate in PESA, which is the Center’s flagship study. The PESA-CNIC-Santander study is already making seminal contributions to our understanding of the origin and progression
Adherence to treatment after an acute myocardial infarction (MI) is essential for efficient secondary prevention. Despite this, many post-MI patients abandon prescribed medication. To address this issue, CNIC
researchers and FERRER laboratories developed a “polypill” including three key drugs prescribed to post-MI patients (aspirin, an ACE-inhibitor, and a statin). Having demonstrated that prescription of the CNIC Polypill significantly
increases treatment adherence among post-MI patients (J Am Coll Cardiol. 2014;64:2071-82), CNIC researchers are now leading a multinational randomized clinical trial supported by the H2020 program. The ongoing SECURE trial (trial
identifier NCT02596126) will enroll >3000 patients soon after an MI and randomize them to standard treatment or a CNIC Polypill-based strategy. Patients will be followed-up for a minimum of 2 years, and the incidence of major cardiovascular
events will be assessed. Trial enrolment will be completed in the third quarter of 2019.
The prescription of beta-blockers to patients after an MI is based on evidence from trials performed in the pre-reperfusion era. While there is solid evidence for their benefit in post-MI patients with reduced
ejection fraction, such evidence is lacking for patients with preserved ejection fraction. Despite this, more than 80% of post-MI patients in this category are prescribed beta-blockers for the rest of their lives. REBOOT (tREatment
with Beta-blockers after myOcardial infarction withOut reduced ejection fracTion) is a multinational trial that will enroll 8600 post-MI patients with a left ventricular ejection fraction above 40%. Patients will be randomized to beta-blocker
therapy (type and dose decided by the attending physician) or to no treatment. The primary endpoint is the composite of all-cause death, reinfarction, or heart failure admission during 3-year follow-up. This trial is coordinated by
the CNIC Clinical Trials Coordination Unit and is run in close collaboration with the Mario Negri Institute of Research in Milan. More than 50 hospitals in Spain and more than 20 in Italy participate in this large- scale project that
will have a major impact on clinical practice. The first patients were enrolled in October 2018.
There is increasing awareness of the association between atherosclerosis and cognitive function, but the mechanisms linking these processes are not fully understood. The Heart-to-Head (H2H) study is testing the hypothesis
that extensive subclinical atherosclerosis is associated with subtle cognitive decline and beta-amyloid deposition in the brain. This transatlantic collaboration is framed within an agreement between the CNIC and Mount Sinai Hospital
in New York and is led by CNIC General Director Valentin Fuster. In Spain, the H2H project is coordinated between the CNIC and 12 de Octubre Hospital. Other university hospitals (Fundación Jiménez Díaz, Clínico San Carlos, and Gregorio
Marañón) participate in the project, which receives funding from the Carlos III Institute of Health through the Proyecto Integrado de Excelencia program. A total of 300 participants are undergoing extensive atherosclerosis phenotyping
(multi-territory 3D vascular ultrasound and cardiac computed tomography) and thorough brain imaging (anatomical and functional magnetic resonance imaging and positron emission tomography (PET)-amyloid scan), as well as cognitive function
testing. Enrollment will be completed in the second quarter of 2019.