coRonary assEssment of Preoperative vaLvulopathy pAtients Using ComputEd Tomographic Angiography (REPLACE)
REPLACE
3 other identifiers
observational
2,644
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2015
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 5, 2015
CompletedFirst Posted
Study publicly available on registry
December 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedSeptember 20, 2016
September 1, 2016
1.1 years
December 5, 2015
September 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Effectiveness of the coronary artery evaluation protocol
48 hours after coronary evaluation (CTA or ICA)
Effectiveness of the coronary artery evaluation protocol
24h after the operation
Other Outcomes (2)
Safety of the coronary examination (CTA or ICA)
24 hours after the examination
Hospitalization cost of patients
During hospital stay, an average of 10 days
Study Arms (2)
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
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.
Eligibility Criteria
The target population in our study comprise pre-operative individuals with valvular disease who are recommended for ICA by the 2014 ACC/AHA guideline
You may qualify if:
- Male ≥ 40 years old; postmenopausal female;
- Patients scheduled to undergo valvular replacement or repair;
- Patients providing written informed consent;
You may not qualify if:
- 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 )
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Fuwai Hospital
Beijing, Beijing Municipality, 100037, China
Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Xijing Hospital
Xian, Shanxi, 710032, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Related Publications (5)
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.
PMID: 17045904BACKGROUNDNishimura 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.
PMID: 24939033BACKGROUNDGilard 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.
PMID: 16697319BACKGROUNDYin 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.
PMID: 25843243BACKGROUNDYin 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.
PMID: 24269265BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bin Lu, MD
Chinese Academy of Medical Sciences, Fuwai Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 30 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 5, 2015
First Posted
December 17, 2015
Study Start
December 1, 2015
Primary Completion
January 1, 2017
Study Completion
June 1, 2017
Last Updated
September 20, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share