An observational study in Coronary Artery Disease and Left Ventricular Cardiac Dysfunction, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
Among 302 studies in Coronary Artery Disease with a site in Italy — 48 open to participants now, 71 under way, 7 of them phase 3. Coronary Artery Disease · Italy.
Among the 302 studies in Coronary Artery Disease with a site in Italy, this one is the 64th largest by planned enrollment of the 113 observational ones, is one of 12 that started in 2025, is one of 113 observational ones, reaches primary completion later than 41 of the 70 other live ones, and was the 298th registered.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 300 is close to the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →48 of the 302 studies in Coronary Artery Disease with a site in Italy are open now, in 12 countries. Each count lists the studies.
Of the 588 Coronary Artery Disease studies recruiting now, 402 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 47 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →302 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 12 started in 2025.
Median enrollment 290 across the 189 interventional studies, 400 across the 113 observational. Of the 151 that completed or were terminated, 35 (23%) have results posted.
101 of 302 have an industry lead sponsor. The 10 most frequent:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS has 7 studies filed under Coronary Artery Disease — fewer than ten, so there is no comparison to draw.
12 of the studies in Coronary Artery Disease with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06410690Centro Cardiologico MonzinoTrustworthy, Integrated Artificial Intelligence Tools for Predicting High-risk CORonary PlaqueS | 2026-11-30 |
| NCT04604782GE HealthcareA Study to Evaluate the Safety and Pharmacokinetics of Regadenoson in Pediatric Patients | 2026-12 |
| NCT06321757Fundación EPICPREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients | 2026-12-30 |
| NCT07817524Fondazione Policlinico Universitario Agostino Gemelli IRCCSClinical Outcome of Coronary Artery Bypass Graft Surgery Versus Percutaneous Coronary Intervention in Patients With Severe Left Ventricular Disfunction (CROWN) | 2026-12-31 |
| NCT07291609Azienda Ospedaliera "Sant'Andrea"Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes | 2026-12-31 |
Among the 302 studies in Coronary Artery Disease with a site in Italy, from their registry updates:
The objective of this study is to evaluate the best treatment strategy in patients with critical coronary artery disease and severe left ventricular dysfunction.
In details, main goal of the study is to compare the clinical outcomes of patients with critical coronary artery disease and severe left ventricular dysfunction undergoing surgical coronary artery bypass grafting with those of patients treated by percutaneous coronary intervention.
Despite CABG being increasingly performed in patients with reduced EF, the literature lacks of data directly comparing the clinical outcomes of surgical versus percutaneous revascularization in patients with left ventricular dysfunction.
The goal of this study is to compare the clinical outcomes of patients with critical coronary artery disease and severe left ventricular dysfunction undergoing surgical coronary artery bypass grafting with those of patients treated by percutaneous coronary intervention (PCI).
All patients affected by coronary artery disease who underwent surgical treatment (coronary artery bypass grafting, CABG) or percutaneous treatment (percutaneous coronary intervention, PCI) between January 2019 and December 2023, and who meet the inclusion and exclusion criteria, will be included in the study. Each patient will be enrolled following an interview and the subsequent signing of the informed consent form. Data will then be recorded in a dedicated database. In detail, the following information will be collected: anamnestic data, description of the performed procedure, preoperative and postoperative laboratory test results, preoperative, intraoperative, and postoperative echocardiographic parameters (including follow-up visits up to 2 years after the procedure), length of stay in the Intensive Care Unit and in the general ward, and data regarding any intraoperative and postoperative complications (death, shock, pericardial effusion, stroke, myocardial infarction, need for postoperative PCI, rehospitalization, heart failure). All data recorded in the database are routinely collected for all patients undergoing this type of intervention, and no additional examinations will be performed on patients included in the study.
All patients affected by coronary artery disease and severe left ventricular disfunction who underwent surgical treatment (coronary artery bypass grafting, CABG) or percutaneous treatment (percutaneous coronary intervention, PCI) between January 2019 and December 2023.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with critical coronary artery disease and severe left ventricular disfunction treated with coronary artery bypass graft surgery
Patients with critical coronary artery disease and severe left ventricular disfunction treated with percutaneous coronary intervention
All-cause mortality
Number of patients who died for any cause after CABG or PCI
Time frame: through study completion, an average of 1 year
Mortality from cardiovascular causes
Number of patients who died for cardiovascolar causes after CABG or PCI
Time frame: through study completion, an average of 1 year
Acute myocardial infarction
Number of patients who experienced myocardial infarction after CABG or PCI
Time frame: through study completion, an average of 1 year
Rehospitalization from cardiovascular reasons
Number of patients who needed rehospitalization after being discharged
Time frame: through study completion, an average of 1 year
Repeated revascularization
Number of patients who needed repeated revascularization after CABG or PCI
Time frame: through study completion, an average of 1 year
Stroke
Number of patients who had stroke after CABG or PCI
Time frame: through study completion, an average of 1 year
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Aug 2025 (actual). Primary completion is estimated for Dec 2026, 16 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS →