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OpenTrials
Completed

NCT Number: NCT05836467

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

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".

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Heart Valve Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele - Cardiac Surgery Department

Milan, 20132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • angina

Treatment and study plan

Valvular interventions

Procedure

Any kind of intervention on heart valves

Primary outcomes

  1. Survival

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

  2. Percutaneous revascularization risk

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

Sponsors and collaborators

Lead sponsor

Michele De Bonis

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 1, 2023
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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