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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-XHGX05 | Other Grant/Funding Number | Peking Union Medical College | |
| 2011-XH3 | Other Grant/Funding Number | Peking Union Medical College |
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| Name | Class |
|---|---|
| Guangdong Provincial People's Hospital | OTHER |
| West China Hospital | OTHER |
| Air Force Military Medical University, China | OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTA Group | 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. |
| |
| ICA Group | Participants in ICA group will undergo ICA as guideline recommend before surgery, coronary artery bypass grafting (CABG) is recommended in patients with significant stenosis |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed tomographic angiography | Other | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the coronary examination (CTA or ICA) | radiation dose, contrast volume and adverse event in 24 hours after the examination | 24 hours after the examination |
| Hospitalization cost of patients | medical cost during the hospital include examination cost, operation cost, drug cost and other cost |
Inclusion Criteria:
Exclusion Criteria:
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The target population in our study comprise pre-operative individuals with valvular disease who are recommended for ICA by the 2014 ACC/AHA guideline
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bin Lu, MD | Contact | 86-10-88322662 | blu@vip.sina.com | |
| Xinshuang Ren, MD | Contact | 86-10-88322651 | caroline_fin@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Bin Lu, MD | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital | Recruiting | Beijing | Beijing Municipality | 100037 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17045904 | Background | Meijboom WB, Mollet NR, Van Mieghem CA, Kluin J, Weustink AC, Pugliese F, Vourvouri E, Cademartiri F, Bogers AJ, Krestin GP, de Feyter PJ. Pre-operative computed tomography coronary angiography to detect significant coronary artery disease in patients referred for cardiac valve surgery. J Am Coll Cardiol. 2006 Oct 17;48(8):1658-65. doi: 10.1016/j.jacc.2006.06.054. Epub 2006 Sep 26. | |
| 24939033 |
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| OTHER |
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Proportion of patients underwent expected CABG will be compared.
| 24h after the operation |
| During hospital stay, an average of 10 days |
| Guangdong General Hospital | Not yet recruiting | Guangzhou | Guangdong | 510080 | China |
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| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | 430022 | China |
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| Xijing Hospital | Not yet recruiting | Xian | Shanxi | 710032 | China |
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| West China Hospital, Sichuan University | Not yet recruiting | Chengdu | Sichuan | 610041 | China |
|
| Background |
| Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Creager MA, Curtis LH, DeMets D, Guyton RA, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Stevenson WG, Yancy CW; American College of Cardiology; American College of Cardiology/American Heart Association; American Heart Association. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Thorac Cardiovasc Surg. 2014 Jul;148(1):e1-e132. doi: 10.1016/j.jtcvs.2014.05.014. Epub 2014 May 9. No abstract available. |
| 16697319 | Background | Gilard M, Cornily JC, Pennec PY, Joret C, Le Gal G, Mansourati J, Blanc JJ, Boschat J. Accuracy of multislice computed tomography in the preoperative assessment of coronary disease in patients with aortic valve stenosis. J Am Coll Cardiol. 2006 May 16;47(10):2020-4. doi: 10.1016/j.jacc.2005.11.085. Epub 2006 Apr 24. |
| 25843243 | Background | Yin WH, Lu B, Gao JB, Li PL, Sun K, Wu ZF, Yang WJ, Zhang XQ, Zheng MW, McQuiston AD, Meinel FG, Schoepf UJ. Effect of reduced x-ray tube voltage, low iodine concentration contrast medium, and sinogram-affirmed iterative reconstruction on image quality and radiation dose at coronary CT angiography: results of the prospective multicenter REALISE trial. J Cardiovasc Comput Tomogr. 2015 May-Jun;9(3):215-24. doi: 10.1016/j.jcct.2015.01.010. Epub 2015 Jan 22. |
| 24269265 | Background | Yin WH, Lu B, Li N, Han L, Hou ZH, Wu RZ, Wu YJ, Niu HX, Jiang SL, Krazinski AW, Ebersberger U, Meinel FG, Schoepf UJ. Iterative reconstruction to preserve image quality and diagnostic accuracy at reduced radiation dose in coronary CT angiography: an intraindividual comparison. JACC Cardiovasc Imaging. 2013 Dec;6(12):1239-49. doi: 10.1016/j.jcmg.2013.08.008. Epub 2013 Oct 23. |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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