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NCT05836467 Clinical Trial

Is Myocardial Revascularization Really Necessary in Patients With ≥50-70% Coronary Stenosis Undergoing Valvular Surgery?

Coronary Artery Disease Clinical Trial

Official title:
Is Myocardial Revascularization Really Necessary in Patients With ≥50-70% Coronary Stenosis Undergoing Valvular Surgery?

Clinical Trial Details — Status: Completed

Administrative data
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

Study information
Verified date April 2023
Source Ospedale San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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".

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Valvular interventions
Any kind of intervention on heart valves

Locations
Country Name City State
Italy IRCCS Ospedale San Raffaele - Cardiac Surgery Department Milan

Sponsors (1)
Lead Sponsor Collaborator
Michele De Bonis

Country where clinical trial is conducted

Italy, 

Outcome
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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