Coronary Artery Disease, Heart Valve Diseases
Conditions
Keywords
Heart Valve Diseases, Coronary Artery Disease, Computed Tomographic Angiography, Preoperative Procedure
Brief summary
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
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.
Interventions
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.
Sponsors
Guangdong Provincial People's Hospital
West China Hospital
Air Force Military Medical University, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
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 )
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of cardiovascular complications and mortality [Perioperative Safety] | POD 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of the coronary artery evaluation protocol | 48 hours after coronary evaluation (CTA or ICA) | Proportion of patients with significant stenosis(stenosis ≥50%) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety of the coronary examination (CTA or ICA) | 24 hours after the examination | radiation dose, contrast volume and adverse event in 24 hours after the examination |
| Hospitalization cost of patients | During hospital stay, an average of 10 days | medical cost during the hospital include examination cost, operation cost, drug cost and other cost |
Countries
China
Contacts
Primary ContactBin Lu, MD
Backup ContactXinshuang Ren, MD
Outcome results
None listed