An observational study in Coronary Artery Disease and Depression, sponsored by Centro Cardiologico Monzino. Status unknown at 2 sites in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-04-20.
Sponsored by Centro Cardiologico Monzino · Observational
Depression after an acute coronary syndrome (ACS) but also at any time after CAD diagnosis, is highly associated with death, and it predicts mortality more than any other risk factor, comorbidity or follow-up events, suggesting that the standard medical therapy may not be sufficient to prevent the poor prognosis in these patients.
This study aims to assess whether depression might affect the response to dual antiplatelet therapy (DAPT) as recommended in coronary artery disease (CAD) patients.
Specific aims:
This study is a multicentre, prospective, observational, case-control, and cross-sectional study. It is planned to enrol 400 patients/subjects (300 patients at Centro Cardiologico Monzino and 100 subjects at IRCCS National Neurological Institute "C. Mondino" Foundation).
Pharmacological treatments in progress will be recorded, administration of Beck Depression Inventory-II (BDI-II), and a fasting blood venous sample (from ante-cubital vein) will be carried out for the haematochemical analyses and for research samples. First morning-urine will be collected for oxidative stress evaluation.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 400 is above the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Centro Cardiologico Monzino is the lead sponsor of 69 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The population of this study includes patients/subjects with or without depression, with CAD (to be enrolled at Centro Cardiologico Monzino) and without CAD (to be enrolled at IRCCS National Neurological Institute "C. Mondino" Foundation)
Centro Cardiologico Monzino: Patients/subjects of both sexes, aged between 18 and 85 years with or without depression, with CAD:
IRCCS National Neurological Institute "C. Mondino" Foundation:
Exclusion Criteria:
CAD patients with depression on standard ASA+CLP therapy.
Other: standard Aspirin (ASA) + clopidogrel (CLP) therapy
CAD Patients without depression on standard ASA+CLP therapy.
Other: standard Aspirin (ASA) + clopidogrel (CLP) therapy
CAD patients with depression on standard ASA+TCG/PSG therapy.
Other: standard Aspirin (ASA) + Ticagrelor (TCG) or Prasugrel (PSG) therapy
CAD patients without depression on standard ASA+TCG/PSG therapy.
Other: standard Aspirin (ASA) + Ticagrelor (TCG) or Prasugrel (PSG) therapy
CAD patients with depression on standard ASA treatment alone at least 1 month after TCG/PSG cessation.
Other: standard ASA therapy
CAD patients without depression on standard ASA treatment alone at least 1 month after TCG/PSG cessation.
Other: standard ASA therapy
Subjects with depression without CAD (DS) are enrolled are enrolled as a comparison group.
Healthy control subjects (HC), subjects without depression and without CAD are enrolled as a comparison group.
ASA100mg + CLP 75mg daily
ASA 100 mg + TCG 90mg/b.i.d or PSG10mg daily
ASA 100 mg daily
Verify whether depression affects the platelet response during ASA plus CLP therapy in CAD patients
Measuring platelet activity markers
Time frame: 3 years
Verify whether depression affects the coagulation during ASA plus CLP therapy in CAD patients
Measuring all the parameters of clot formation and lysis collected by thromboelastography analyses
Time frame: 3 years
Verify whether depression affects oxidative stress during ASA plus CLP therapy in CAD patients
Measuring lipid peroxidation
Time frame: 3 years
Assess the effects of ASA plus TCG/PSG therapy on platelet response in CAD patients with depression
Measuring platelet activity markers
Time frame: 3 years
Assess the effects of ASA plus TCG/PSG therapy on coagulation in CAD patients with depression
Measuring all the parameters of clot formation and lysis collected by thromboelastography analyses
Time frame: 3 years
Assess the effects of ASA plus TCG/PSG therapy on oxidative stress in CAD patients with depression
Measuring lipid peroxidation
Time frame: 3 years
Assess whether there is or not the activation of platelet response after cessation of dual antiplatelet therapy in CAD patients with depression
Measuring platelet activity markers
Time frame: 3 years
Assess whether there is or not the activation of coagulation after cessation of dual antiplatelet therapy in CAD patients with depression
Measuring all the parameters of clot formation and lysis collected by thromboelastography analyses
Time frame: 3 years
Assess whether there is or not the activation of oxidative stress after cessation of dual antiplatelet therapy in CAD patients with depression
Measuring lipid peroxidation
Time frame: 3 years
CLP metabolism in patients with depression and CAD
Measuring the CLP active metabolite
Time frame: 3 years
Epigenetic modification in patients with depression and CAD
Through miRNAs analysis
Time frame: 3 years
DNA methylation in patients with depression and CAD
Measuring DNA methylation levels of two 5'-C-phosphate-G-3' (CpG) dinucleotides on P2Y12
Time frame: 3 years
Impact of depression on oxidative stress in patients without CAD
Measuring platelet activity markers
Time frame: 3 years
Effect of depression on oxidative stress in patients without CAD
Measuring lipid peroxidation
Time frame: 3 years
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centro Cardiologico Monzino