Coronary Artery Disease Clinical Trial
Official title:
Is Myocardial Revascularization Really Necessary in Patients With ≥50-70% Coronary Stenosis Undergoing Valvular Surgery?
NCT number | NCT05836467 |
Other study ID # | NO-CABG |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 5, 2019 |
Est. completion date | October 15, 2019 |
Verified date | April 2023 |
Source | Ospedale San Raffaele |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
It is well documented in the literature that myocardial revascularization during valve surgery increases the risk of early mortality and morbidity. According to the most recent version of the European Guidelines, the possibility of myocardial revascularization via coronary artery bypass should be evaluated in patients with an indication for surgical treatment of heart valve disease but with coronary artery stenosis ≥ 50-70%. In this study, patients hospitalized for surgical heart valve disease, with occasional pre-operative finding of ≥ 50-70% coronary artery stenosis, without angina, are examined. After interdisciplinary discussion in the Heart Team, it was decided not to treat coronary artery disease during valve surgery. The aim is to evaluate the short and medium-term results of this "conscious omission".
Status | Completed |
Enrollment | 77 |
Est. completion date | October 15, 2019 |
Est. primary completion date | October 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - adult patients - Presence of valve disease of surgical interest. - Occasional pre-operative finding of coronary stenosis >= 50-70%. Exclusion Criteria: - angina |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Ospedale San Raffaele - Cardiac Surgery Department | Milan |
Lead Sponsor | Collaborator |
---|---|
Michele De Bonis |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival | through study completion, a minimum of 18 months | ||
Primary | Percutaneous revascularization risk | through study completion, a minimum of 18 months |
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