Single Cell Sequencing and Multidimensional Omics Studies in Cardiovascular and Neurological Diseases

NCT06114095 | Recruiting

• 1 other identifier: YXLL-KY-2023(038)
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Research purpose Using single-cell sequencing, 3D/4D genomics and multidimensional omics technologies to reveal the complex cellular and molecular regulatory networks of cardiovascular and nervous system diseases, unique phenotypic changes of specific cell types, and different gene expression patterns, identify cell types and cell subsets associated with cardiovascular and nervous system diseases, and discover disease-related genes. To reveal new pathological mechanisms of related diseases and develop new diagnosis and treatment methods. Research background Cardiovascular and nervous system diseases such as arrhythmias (atrial fibrillation, ventricular tachycardia, ventricular fibrillation, postoperative vascular stenosis injury, etc.), heart failure, atherosclerosis (coronary heart disease, stroke, peripheral vascular disease, carotid atherosclerosis, etc.), epilepsy, moyamoya disease, etc., are currently leading to the main diseases affecting the health and death of residents in China. The data integration method based on single-cell sequencing, multi-omics data, and machine learning to analyze molecular level changes in cardiovascular and nervous system-related diseases can help deepen the research on the pathogenesis of cardiovascular and nervous system-related diseases and provide new ideas for the prevention and treatment of related diseases.

Conditions

Nervous System Diseases; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (5)

• Blood collection

  ① Collect 5-10ml blood of the subject, centrifuge, collect serum and plasma, temporarily do not test, can be immediately frozen at low temperature, the lower the temperature is better, if not repeated freezing and thawing in the middle, can be stored for one month below -20℃, can be stored for three months below -80℃. ② Citrate anticoagulant and plasma collection: Sodium citrate acts as an anticoagulant by acting on calcium ion chelation in blood samples, recommended by the National Committee for Standardization of Clinical Laboratories (NCCLS) is 3.2% or 3.8%, and the anticoagulant to blood ratio is 1: 9, mainly used in the fibrinolytic system (prothrombin time, thrombin time, activated partial thrombin time, fibrinogen). When taking blood, attention should be paid to taking enough blood to ensure the accuracy of the test results, and the blood should be gently reversed and mixed 5-8 times immediately after taking blood.

  One month after the patient is clinically diagnosed with the above disease

• stool samples

  ① Sampling should be taken at the non-eating stage between 6am and 9am Before sampling, stool must be emptied into a clean and dry urinal or container containing filter paper. Note: Urine should not be mixed into the container. ② Use a small spoon in the sampler to collect feces. Note: In order to prevent contamination of the stool surface, gently peel the surface with a sampling spoon, and sample the inside of the stool, placing it in an average of three feces tubes. ③ After sampling, close the cover of the collector and mark the name and sampling time on the collector with a pen. Store at room temperature for 1 day, long-term storage at -80℃. Note: The sampler should not take antibiotics or other drugs for 45 days.

  One month after the patient is clinically diagnosed with the above disease

• urine specimen

  The first urine of the experimental group was collected in the morning and used for urine routine detection. A clean, covered, disposable volume is usually used for urine collection, and the volume of the container for urine collection is generally greater than 20mL. The container for urine collection should be labeled, including the patient's name, the specimen code and the time of urine collection. Urine should be taken within two hours as soon as possible

  One month after the patient is clinically diagnosed with the above disease

• Single cell sequencing(Disease Group)

  During surgical treatment, at least 1mg of pathological waste tissue was taken as a sample The corresponding single cell samples were obtained through the steps of preservation, digestion, sorting and library building. Sample collection of patients with atrial fibrillation: A small amount of useless left atrial appendage tissue 100mg was taken as a sample during surgical treatment of atrial fibrillation patients. (The tissues used in this study were either residual tissues or abandoned tissues, and both were necessary for surgical resection, so there was no additional risk for subjects.) Carotid atherosclerosis samples were collected: During the surgical treatment of carotid atherosclerotic plaque endarterectomy, at least 1mg of the central tissue of discarded vascular plaque was collected as a sample. Moyamoya disease sample collection: During cerebrovascular bypass surgery for Moyamoya disease, at least 1mg of discarded vascular tissue was collected as a sample.

  Collected during surgical treatment

• Single cell sequencing (control group)

  During surgical treatment, at least 1mg of pathological waste tissue was collected as a sample .The corresponding single cell samples were obtained through the steps of preservation, digestion, sorting and library building. Atrial fibrillation control heart tissue sample collection: Atrial fibrillation control heart tissue was 100mg of cut waste tissue from heart transplant donor heart. Carotid atherosclerosis control sample collection: During the surgical treatment of carotid atherosclerotic plaque endarterectomy, at least 1mg of marginal tissue of discarded vascular plaque was collected as control samples. Moyamoya disease control sample collection: During cerebrovascular bypass surgery in non-moyamoya disease patients, at least 1mg of pruned waste vascular tissue was collected as a sample.

  Collected during surgical treatment

Study Arms (2)

Disease group

Disease-specific experimental cohort of cardiovascular and neurological diseases (atrial fibrillation secondary to valvular heart disease, carotid atherosclerosis, moyamoya disease)

Healthy control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Based on the hospital diagnosis results, after the subjects are identified as the subjects of this experiment, they will be explained about the experiment process and informed of the benefits/risks, and they will sign the informed consent and enter the group voluntarily.

You may qualify if:

• Moderate or above mitral valve disease; The occurrence of atrial fibrillation was recorded by 12-lead electrocardiogram or 24-hour holter electrocardiogram. 3.18≤ Age ≤75 years old.
• No moderate or above mitral valve disease; No history of atrial fibrillation, 24-hour holter electrocardiogram did not record the occurrence of atrial fibrillation. 3.18≤ Age ≤75 years old.
• Carotid atherosclerosis was confirmed by ultrasound, CTA and other imaging diagnosis. 2.18≤ Age ≤75 years old.
• Imaging diagnosis confirmed moyamoya disease; 2.18≤ Age ≤75 years old.
• Imaging diagnosis confirmed no moyamoya disease; 2.18≤ Age ≤75 years old.

You may not qualify if:

• Coronary heart disease, myocardial infarction, hyperthyroidism, severe hepatic and renal insufficiency, benign and malignant tumors, etc. Dilated cardiomyopathy, hypertrophic cardiomyopathy, congenital heart disease, heart failure and other non-valvular factors cause atrial fibrillation.
• Coronary heart disease, myocardial infarction, hyperthyroidism, severe hepatic and renal insufficiency, benign and malignant tumors, etc. Dilated cardiomyopathy, hypertrophic cardiomyopathy, congenital heart disease, heart failure, etc.
• History of carotid vascular surgery or trauma
• No plaque margin tissue or marginal tissue injury was found in abandoned vessels in the same patient.
• Previous history of cerebrovascular surgery or trauma.
• Previous history of cerebrovascular surgery or trauma.

Sponsors & Collaborators

• Tao Xin: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, 250000, China

RECRUITING

Related Publications (4)

• Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.

  PMID: 32860505 BACKGROUND

• Hu F, Zheng L, Liu S, Shen L, Liang E, Ding L, Wu L, Chen G, Fan X, Yao Y. Avoidance of Vagal Response During Circumferential Pulmonary Vein Isolation: Effect of Initiating Isolation From Right Anterior Ganglionated Plexi. Circ Arrhythm Electrophysiol. 2019 Dec;12(12):e007811. doi: 10.1161/CIRCEP.119.007811. Epub 2019 Nov 25.

  PMID: 31760820 BACKGROUND

• Garnvik LE, Malmo V, Janszky I, Ellekjaer H, Wisloff U, Loennechen JP, Nes BM. Physical activity, cardiorespiratory fitness, and cardiovascular outcomes in individuals with atrial fibrillation: the HUNT study. Eur Heart J. 2020 Apr 14;41(15):1467-1475. doi: 10.1093/eurheartj/ehaa032.

  PMID: 32047884 BACKGROUND

• Horn P, Bueltmann E, Buch CV, Schmiedek P. Arterio-embolic ischemic stroke in children with moyamoya disease. Childs Nerv Syst. 2005 Feb;21(2):104-7. doi: 10.1007/s00381-004-0962-y. Epub 2004 May 18.

  PMID: 15148620 BACKGROUND

MeSH Terms

Conditions

Nervous System Diseases; Cardiovascular Diseases

Study Officials

• Xin Tao

  The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Tao, Director of Neurosurgery

CONTACT

18888376796; drxintao@yeah.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Neurosurgery

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: November 2, 2023
• Study Start: April 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: April 30, 2026
• Last Updated: November 2, 2023

Record last verified: 2023-10

Locations

CN (1)