Clinical trial NCT02632617: coRonary assEssment of Preoperative vaLvulopathy pAtients Using ComputEd Tomographic Angiography (REPLACE)
Official title: coRonary assEssment of Preoperative vaLvulopathy pAtients Using ComputEd Tomographic Angiography (REPLACE)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Valve Diseases
Coronary Artery Disease
Keywords: Heart Valve Diseases
Coronary Artery Disease
Computed Tomographic Angiography
Preoperative Procedure
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial People's Hospital
name: West China Hospital
name: Air Force Military Medical University, China
name: Wuhan Union Hospital, China
First posted: 2015-12-17
Enrollment: 2644
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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.

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 )

Primary outcomes:
measure: Incidence of cardiovascular complications and mortality [Perioperative Safety]
timeFrame: POD 30 days
Secondary outcomes:
measure: Effectiveness of the coronary artery evaluation protocol
timeFrame: 48 hours after coronary evaluation (CTA or ICA)
measure: Effectiveness of the coronary artery evaluation protocol
timeFrame: 24h after the operation
Other outcomes:
measure: Safety of the coronary examination (CTA or ICA)
timeFrame: 24 hours after the examination
measure: Hospitalization cost of patients
timeFrame: During hospital stay, an average of 10 days
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Xian
country: China
facility: Xijing Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Bin Lu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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. No abstract available.
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