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Clinical Trials/NCT05836467
NCT05836467
Completed
N/A

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

Michele De Bonis1 site in 1 country77 target enrollmentOctober 5, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Michele De Bonis
Enrollment
77
Locations
1
Primary Endpoint
Survival
Status
Completed
Last Updated
3 years ago

Overview

Brief 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".

Registry
clinicaltrials.gov
Start Date
October 5, 2019
End Date
October 15, 2019
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Michele De Bonis

Chief of Cardiac Surgery of Advanced and Research Therapies

Ospedale San Raffaele

Eligibility Criteria

Inclusion Criteria

  • adult patients
  • Presence of valve disease of surgical interest.
  • Occasional pre-operative finding of coronary stenosis \>= 50-70%.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Survival

Time Frame: through study completion, a minimum of 18 months

Percutaneous revascularization risk

Time Frame: through study completion, a minimum of 18 months

Study Sites (1)

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