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

NCT ID: NCT05836467

Last Updated: 2023-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-05

Study Completion Date

2019-10-15

Brief Summary

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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".

Detailed Description

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Conditions

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Coronary Artery Disease Heart Valve Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Valvular interventions

Any kind of intervention on heart valves

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* angina
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Michele De Bonis

OTHER

Sponsor Role lead

Responsible Party

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Michele De Bonis

Chief of Cardiac Surgery of Advanced and Research Therapies

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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IRCCS Ospedale San Raffaele - Cardiac Surgery Department

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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NO-CABG

Identifier Type: -

Identifier Source: org_study_id

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