coRonary assEssment of Preoperative vaLvulopathy pAtients Using ComputEd Tomographic Angiography (REPLACE)

Study Overview
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Brief Summary
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Preoperative detection of combined coronary artery disease by invasive coronary angiography (ICA) is recommended in American Heart Association (AHA)/American College of Cardiology (ACC) guidelines for most patients (>40 yrs male or postmenopausal female) scheduled for heart valve surgery, but the low incident rate of coronary artery disease implied guidelines for the vast majority who ultimately will not undergo revascularization. Computed tomography angiography (CTA) has emerged as an alternative diagnosis procedure, which has the following advantages: non-invasive, low cost, provide information of lung and mediastinum. Our study is to evaluate the feasibility of computed tomography, instead of conventional invasive coronary angiography in evaluating coronary artery lesion prior to the heart valvular operation.

Detailed Description
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Valvular heart disease is common in China, either rheumatic or degenerative, and valvular repair or replacement surgery is the important therapeutic method. In all forms of heart valvular disease, combined coronary artery disease worsens perioperative prognosis. Preoperative detection of combined coronary artery disease with invasive coronary angiography is recommended in most patients scheduled for valve surgery, while incidence rate of coronary artery disease in patients with valvular disease showed that only 3%-19% patients were diagnosed with significant stenosis. Although invasive coronary angiography is considered a safe procedure, it still carries a small risk of major (death, stroke, or vascular dissection) and minor (inguinal hematoma) complications. Furthermore, the catheterization procedure is rather expensive, as its invasive nature involves admission to a hospital and requires surveillance by an experienced team. As a non-invasive alternative diagnosis procedure, coronary computed tomographic angiography has showed promising performance with high negative predictive value (95%-100%). Furthermore, computed tomography is a noninvasive procedure with low risk and cost, and it can be easily performed at the clinic. Except for evaluation of coronary artery, computed tomography can also provide information of lung, mediastinum and cardiac structure, which may help physicians make early diagnosis and treatment. Computed tomography is not routinely utilized in clinical practice. Our study is a prospective multicenter study to assess the feasibility and safety of adding computed tomography as a gatekeeper and perform invasive coronary angiography selectively prior to valvular surgeries.

Official Title
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coRonary assEssment of Preoperative vaLvulopathy pAtients Using ComputEd Tomographic Angiography (REPLACE)

Conditions
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Heart Valve Diseases, Coronary Artery Disease

Intervention / Treatment
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* Other: Computed tomographic angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male ≥ 40 years old; postmenopausal female; Patients scheduled to undergo valvular replacement or repair; Patients providing written informed consent; Exclusion Criteria: Patients with definite coronary artery disease history (Prior myocardial infarction, percutaneous coronary intervention or CABG); Patients with objective evidence of myocardial ischemia; Underwent CTA or ICA in 6 months; With contraindications to CTA/ICA (allergic to contrast medium, peripheral arterial occlusive disease, chronic kidney disease with estimated glomerular filtration rate (eGFR) less than 15ml/min.1.73m2 )

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CTA Group<br>Participants in CTA group will primarily receive computed tomographic angiography examination before surgery. Those with positive findings in CTA (≥50% diameter stenosis in main coronary artery) or uncertain diagnosis caused by motion artifact or calcium artifact are required to undergo ICA, and coronary artery bypass grafting (CABG) is recommended in patients with significant stenosis according to the ICA result. Participants with negative findings in CTA do not need further coronary artery evaluation, and CABG won't be performed during the surgery. | Other: Computed tomographic angiography<br>* Preoperative examination is needed in patients with valvular disease. The invasive coronary angiography is used for patients in ICA group, while the computed tomographic angiography is used as a gatekeeper and invasive coronary angiography is selectively used for patients in CTA group.<br>* Other names: CTA;|
| ICA Group<br>Participants in ICA group will undergo ICA as guideline recommend before surgery, coronary artery bypass grafting (CABG) is recommended in patients with significant stenosis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of cardiovascular complications and mortality [Perioperative Safety] | Incidence rates of intraoperative and postoperative cardiovascular complications and mortality caused by coronary stenosis within 30 days after the surgery will be compared between the two groups. | POD 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the coronary artery evaluation protocol | Proportion of patients with significant stenosis(stenosis ≥50%) | 48 hours after coronary evaluation (CTA or ICA) | 
| Effectiveness of the coronary artery evaluation protocol | Proportion of patients underwent expected CABG will be compared. | 24h after the operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Valve Diseases, Coronary Artery Disease, Computed Tomographic Angiography, Preoperative Procedure