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

NCT05836467 | Completed

• 1 other identifier: NO-CABG
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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".

Conditions

Coronary Artery Disease; Heart Valve Diseases

Outcome Measures

Primary Outcomes (2)

• Survival

  through study completion, a minimum of 18 months

• Percutaneous revascularization risk

  through study completion, a minimum of 18 months

Interventions

Valvular interventions PROCEDURE

Any kind of intervention on heart valves

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with any valvulopathy requiring sugery, with also critical coronary stenosis of 50-70% or more.

You may qualify if:

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

You may not qualify if:

• angina

Sponsors & Collaborators

• Michele De Bonis: lead

Study Sites (1)

IRCCS Ospedale San Raffaele - Cardiac Surgery Department

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Coronary Artery Disease; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Cardiac Surgery of Advanced and Research Therapies

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: May 1, 2023
• Study Start: October 5, 2019
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2019
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)