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临床试验/NCT05791617
NCT05791617招募中不适用

PET/MR in Post Stroke Cardiac Inflammation Study

Lawson Health Research Institute1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
12
试验地点
1
主要终点
Cardiac Inflammation Levels at 30±5 Days Post-Stroke measured by PET/MR Scanning

研究概览

简要总结

Patients with stroke have a 25x higher risk of cardiovascular complications within the first 30 days of the event compared to individuals without stroke. The mechanisms behind these complications are not well understood. Evidence suggests that inflammation plays a central role. With the present proof-of-concept prospective cohort study, the investigators aim to demonstrate that patients develop cardiac inflammation after stroke by performing positron emission tomography (PET) magnetic resonance imaging (MRI) of the heart within 15 days after stroke. As a secondary aim, the investigators will evaluate whether post-stroke cardiac inflammation persists at 3 months after stroke. The control group will be comprised of age- and sex-matched individuals without stroke.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years willing to cons Age ≥18 years willing to consent
  • Patients with acute ischemic stroke in the right or left MCA territory, admitted to University Hospital, London Health Sciences Centre (LHSC) or evaluated at LHSC's Urgent TIA and Stroke Prevention Clinic. Acute ischemic stroke is defined as acute onset focal symptoms matching an acute brain infarct documented on a Head CT or on diffusion weighted imaging (DWI) MRI of the brain showing restricted diffusion.
  • Willing to consent.

排除标准

  • History of known heart disease defined as known atrial fibrillation, prior myocardial infarction, coronary artery disease, heart failure, prior cardiovascular surgery or percutaneous intervention
  • Stroke in the previous 3 months before the qualifying stroke.
  • High-sensitivity Troponin-T (HS-TnT) >100 ng/L on routine standard of care acute stroke bloodwork.
  • Clinically or neurologically unstable patients as per the treating physician.
  • Ongoing infection or recent infection within the previous 3 months.
  • Surgery within 3 months before the stroke.
  • Concurrent inflammatory conditions (connective tissue diseases, rheumatological disease, etc.) or use of anti-inflammatory medications.
  • Contraindications to the use of gadolinium (e.g., pregnancy, stage IV renal insufficiency)
  • Subjects will be excluded if they fail the St. Joseph's Health Care standard MRI screening questionnaire. Briefly, this questionnaire screens for: Heart Pacemakers / Wires, Aneurysm Clips, Shunt / Surgical Clips, Shrapnel / Bullets, Dentures or Metal braces, Intra-Uterine Device, Heart Valves, Ear Implants, Prostheses, Medication Patches (Nicoderm, Habitrol, Transderm-Nitro, etc.), Claustrophobia, History of a head or eye injury involving metal fragments. Patients with an eGFR < 40 will be excluded, as impaired renal function places the patient at a higher risk for a rare reaction to Gd-DTPA, the MRI contrast agent.

结局指标

主要结局

Cardiac Inflammation Levels at 30±5 Days Post-Stroke measured by PET/MR Scanning

时间窗: At 30 days±5 post stroke

Cardiac inflammation as measure on PET/MR scanning.

Cardiac Inflammation Levels at 90±5 Days Post-Stroke measured by PET/MR Scanning

时间窗: At 90±5 days compared to first 30 days±5 post-stroke

Cardiac inflammation as measure on PET/MR scanning.

次要结局

  • Change in systemic inflammatory markers between 30±5 and 90±5 days post-stroke(At 90±5 days compared to first 30±5 days)
  • Change in B-Type Natriuretic Peptide (NT-proBNP) and HS-TnT levels between 30±5 days and 90±5 days post-stroke.(At 90±5 days compared to first 30±5 days post stroke)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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