Clinical Research Directory

Accessing the Clarity and Acceptability of Recruitment Materials for a Study on Thoracic Aortic Disease Surveillance

People who are invited to take part in health research are usually given written information, such as invitation letters, and information sheets. These documents are essential because they help people understand what the study involves and decide whether they want to take part. However, many studies have shown that research information is often too complex, too long, or written in technical language. This can make it difficult for people to fully understand the study and give informed consent. This study aims to assess how clear, accessible, and acceptable draft research documents are for a proposed future doctoral study related to thoracic aortic disease. Thoracic aortic disease is a long-term condition that requires regular monitoring, and people in surveillance programmes may be invited to take part in research. It is therefore important that study information is clear, sensitive, and easy to understand. In this study, staff and students from the University's School of Health Sciences will be asked to review draft recruitment materials. These materials include a study invitation, an information sheet, and interview guide. Participants will be asked to give feedback on how easy the documents are to read, whether the information is clear, whether the tone feels appropriate, and whether the amount of information feels reasonable. The study will also use a standard readability tool to assess whether the documents are written at a level suitable for the public. This research does not involve patients and is considered low risk. Its purpose is to improve research materials before they are used with patients, helping to support informed consent, reduce confusion, and improve ethical and inclusive research practice in future studies.

Pathogenetic Basis of Aortopathy and Aortic Valve Disease

The main purpose of this study is to define the complex genetic and pathogenic basis of thoracic aortic aneurysm (TAA) and other forms of aortopathy and/or aortic valve disease by identifying novel disease-causing genes and by identifying important genetic modifiers for aortic and aortic valve disease severity.

Real-world Study on Fenestrated Stent for Thoracic Aortic Dissection

Study Title: "Multi-center Real-world Study on Straight Tubular Thoracic Aortic Perforated Stent-Graft System for Treating Thoracic Aortic Dissection" Purpose: This study aims to evaluate the effectiveness of the Talos stent-graft system, a new device designed to treat aortic dissection (a life-threatening condition where the inner layer of the aorta tears). The stent has unique features like perforations and tapered design to reduce complications compared to traditional stents. Key Features of the Talos Stent: Longer length to cover more of the damaged aorta Perforated design at the distal end to improve blood flow Tapered shape to better match natural aortic anatomy Potentially reduces risks like new tears or spinal cord ischemia Study Details: Type: Real-world study (combining prospective and retrospective data) Duration: 3 years (2024-2027) Participants: 320 patients across 5 major hospitals in Shanghai Follow-up: Regular check-ups at 1, 3, 6, 12, and 24 months post-surgery Who Can Participate? Patients may qualify if they: Are ≥18 years old Have aortic dissection requiring treatment Have suitable blood vessels for stent placement Can commit to follow-up visits Who Cannot Participate? Patients with: Connective tissue disorders (e.g., Marfan syndrome) Active infections or cancer with limited life expectancy Severe allergies to stent materials/contrast dye Pregnancy or planning pregnancy What Does Participation Involve? Pre-Surgery: Physical exams, blood tests, CT scans Surgery: Minimally invasive stent placement via groin artery Post-Surgery: Blood pressure management, antiplatelet medication (e.g., aspirin) Follow-up: CT scans and quality-of-life questionnaires Potential Benefits: Improved aortic healing Reduced need for repeat surgeries Better quality of life (measured by VascuQoL questionnaire) Possible Risks: Standard stent risks (bleeding, infection, allergic reactions) Device-related complications (leaks, migration, new tears) Organ ischemia (reduced blood flow to kidneys/other organs) Safety Monitoring: Independent review of all CT scans 24/7 access to vascular specialists Immediate reporting of any complications Ethical Protections: Approved by ethics committees at all hospitals Voluntary participation with signed consent Right to withdraw anytime without affecting care For Healthcare Providers: This investigator-initiated study (IIS) is funded by Shanghai Science \& Technology Commission. It uses standardized protocols across centers with electronic data capture (EDC) for consistency. The primary endpoint is 12-month treatment success (defined as technical success + no reintervention). Secondary endpoints include aortic remodeling rates and complication profiles. Contact Information: Principal Investigator: Dr. Meng Qingyou Institution: Shanghai General Hospital Phone: +86-133-0621-1019

Comparing Hypothermic Temperatures During Hemiarch Surgery

Hypothermic circulatory arrest is an important surgical technique, allowing complex aortic surgeries to be performed safely. Hypothermic circulatory arrest provides protection to cerebral and visceral organs, but may result in longer cardiopulmonary bypass times during surgery, increased risks of bleeding, inflammation, and neuronal injury. To manage these consequences, a trend towards warmer core body temperatures during circulatory arrest has emerged. This trial will randomize patients to either mild (32°C) or moderate (26°C) hypothermia during aortic hemiarch surgery to determine if mild hypothermia reduces the length of cardiopulmonary bypass time and other key measures of morbidity and mortality.