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

Coronary Artery Disease Clinical Trial

— REPLACE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02632617
• Other study ID #: 2015-681
• Secondary ID: 2012-XHGX052011-
• Status: Recruiting
• Phase: N/A
• First received: December 5, 2015
• Last updated: September 17, 2016
• Start date: December 2015
• Est. completion date: June 2017

Study information

• Verified date: September 2016
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Bin Lu, MD
• Phone: 86-10-88322662
• Email: blu[@]vip.sina.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2644
• Est. completion date: June 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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 )

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Valve Diseases
• Myocardial Ischemia

Intervention

Other:
• Computed tomographic angiography
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.

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing	Beijing
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Guangdong General Hospital	Guangzhou	Guangdong
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Xijing Hospital	Xian	Shanxi

Sponsors (5)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital	Fourth Military Medical University, Guangdong General Hospital, West China Hospital, Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

References & Publications (5)

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. Epub 2006 Apr 24. — View Citation

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. Epub 2006 Sep 26. — View Citation

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. Review. Erratum in: J Thorac Cardiovasc Surg. 2014 Oct 21;64(16):1763. Dosage error in article text. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Other	Hospitalization cost of patients	medical cost during the hospital include examination cost, operation cost, drug cost and other cost	During hospital stay, an average of 10 days	No
Primary	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	Yes
Secondary	Effectiveness of the coronary artery evaluation protocol	Proportion of patients with significant stenosis(stenosis =50%)	48 hours after coronary evaluation (CTA or ICA)	No
Secondary	Effectiveness of the coronary artery evaluation protocol	Proportion of patients underwent expected CABG will be compared.	24h after the operation	No