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

NCT ID: NCT02632617

Last Updated: 2016-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2644 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-06-30

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.

Conditions

Heart Valve Diseases; Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Computed tomographic angiography

Intervention Type: 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.

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

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

CTA

Eligibility Criteria

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 )

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: collaborator

West China Hospital

OTHER

Sponsor Role: collaborator

Air Force Military Medical University, China

OTHER

Sponsor Role: collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: collaborator

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bin Lu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bin Lu, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

Fuwai Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Guangdong General Hospital

Guangzhou, Guangdong, China

Site Status: NOT_YET_RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status: NOT_YET_RECRUITING

Xijing Hospital

Xian, Shanxi, China

Site Status: NOT_YET_RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Bin Lu, MD

Role: CONTACT

blu@vip.sina.com

86-10-88322662

Xinshuang Ren, MD

Role: CONTACT

caroline_fin@126.com

86-10-88322651

Facility Contacts

Bin Lu, MD

Role: primary

blu@vip.sina.com

86-10-88322662

Xinshuang Ren, MD

Role: backup

caroline_fin@126.com

86-10-88322651

Hui Liu, MD

Role: primary

13580352002@139.com

8613580352002

Hui Gu, MD

Role: backup

18201287661@126.com

86-0531-68776770

Heshui Shi, MD

Role: primary

13871089008@163.com

13871089008

Minwen Zheng, MD

Role: primary

zhengmw2007@163.com

13700228067

Jianqun Yu, MD

Role: primary

cjr.yujianqun@vip.163.com

18628276479

References

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.

Reference Type: BACKGROUND

PMID: 17045904 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24939033 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16697319 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25843243 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24269265 (View on PubMed)

Other Identifiers

2012-XHGX05

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2011-XH3

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2015-681

Identifier Type: -

Identifier Source: org_study_id