Heart Valve DiseasesREPLACENCT02632617
coRonary assEssment of Preoperative vaLvulopathy pAtients Using ComputEd Tomographic Angiography (REPLACE)
An observational study of Heart Valve Diseases and Coronary Artery Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 5 sites in China.
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… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Heart Valve Diseases, Coronary Artery Disease
- What is being tested?
- Computed tomographic angiography
- How many people
- 2,644 participants
- Where
- 5 sitesChina
- Study dates
- Dec 2015to Jun 2017
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population in our study comprise pre-operative individuals with valvular disease who are recommended for ICA by the 2014 ACC/AHA guideline
Who may be able to join
- Male ≥ 40 years old; postmenopausal female;
- Patients scheduled to undergo valvular replacement or repair;
- Patients providing written informed consent;
Who cannot join
- 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 )
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Fuwai Hospital
Beijing, Beijing Municipality, 100037
Bin Lu, MD, 86-10-88322662, blu@vip.sina.com
Xinshuang Ren, MD, 86-10-88322651, caroline_fin@126.com
- Not yet recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Jianqun Yu, MD, 18628276479, cjr.yujianqun@vip.163.com
- Not yet recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 510080
Hui Liu, MD, 8613580352002, 13580352002@139.com
Hui Gu, MD, 86-0531-68776770, 18201287661@126.com
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Heshui Shi, MD, 13871089008, 13871089008@163.com
- Not yet recruiting
Xijing Hospital
Xian, Shanxi, 710032
Minwen Zheng, MD, 13700228067, zhengmw2007@163.com
About this study
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.
Read the 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
- Being tested
- Computed tomographic angiography
- Keywords
- Heart Valve Diseases, Coronary Artery Disease, Computed Tomographic Angiography, Preoperative Procedure
- Medical subject headings
- Heart Valve Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed tomographic angiographyOther
Also called CTA
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Computed tomographic angiography | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: POD 30 days
Secondary outcomes (2)
Effectiveness of the coronary artery evaluation protocol
Proportion of patients with significant stenosis(stenosis ≥50%)
Measured: 48 hours after coronary evaluation (CTA or ICA)
Effectiveness of the coronary artery evaluation protocol
Proportion of patients underwent expected CABG will be compared.
Measured: 24h after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJan 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,644 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Bin Lu, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Bin Lu, MD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632617
- Sponsor's protocol ID
- 2015-681
- Other IDs
- 2012-XHGX05, 2011-XH3
- Acronym
- REPLACE
- Status last verified
- Sep 2016
- First submitted
- 5 Dec 2015
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 17045904Nishimura 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.
PubMed 24939033Gilard 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.
PubMed 16697319Yin 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.
PubMed 25843243Yin 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.
PubMed 24269265
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- coRonary assEssment of Preoperative vaLvulopathy pAtients Using ComputEd Tomographic Angiography (REPLACE)
- ClinicalTrials.gov ID
- NCT02632617
- Acronym / sponsor ID
- REPLACE / 2015-681
- Conditions
- Heart Valve Diseases, Coronary Artery Disease
- Keywords
- Heart Valve Diseases, Coronary Artery Disease, Computed Tomographic Angiography, Preoperative Procedure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,644 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Collaborators
- 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
- Study start
- Dec 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTA Group | – | Other: Computed tomographic angiographyParticipants 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 |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population in our study comprise pre-operative individuals with valvular disease who are recommended for ICA by the 2014 ACC/AHA guideline
Key inclusion criteria (3 listed)
- Male ≥ 40 years old; postmenopausal female;
- Patients scheduled to undergo valvular replacement or repair;
- Patients providing written informed consent;
Key exclusion criteria (4 listed)
- 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 )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed tomographic angiographyAlso: CTAPreoperative 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. | Other | CTA Group |
Primary outcome
Incidence of cardiovascular complications and mortality [Perioperative Safety]
Time frame: 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.
2 secondary outcomes
Effectiveness of the coronary artery evaluation protocol
Time frame: 48 hours after coronary evaluation (CTA or ICA)
Effectiveness of the coronary artery evaluation protocol
Time frame: 24h after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- Background: PubMed 17045904Meijboom 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.
- Background: PubMed 24939033Nishimura 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.
- Background: PubMed 16697319Gilard 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.
- Background: PubMed 25843243Yin 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.
- Background: PubMed 24269265Yin 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bin Lu, MD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Valve Diseases and Coronary Artery Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bin Lu, MD (86-10-88322662, blu@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cardiovascular complications and mortality [Perioperative Safety] (time frame: POD 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02632617, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2016.