Coronary Atherosclerosis T1-Weighted Characterization (CATCH)

Обзор

This study proposes to develop an MRI technique named Coronary Atherosclerosis T1-weighed Characterization (CATCH) that will improve the quality and reliability of coronary atherosclerosis evaluation, as well as simplify the scanning process and significantly shorten imaging time compared with conventional imaging methods.

Подробное описание

Approximately 110 healthy male/female adult "normals" or "controls" and 40 male/female adult outpatients who are suspected of having or have been diagnosed with coronary artery disease will be recruited. All subjects will be asked to undergo either a non-contrast MRI or a contrast-enhanced MRI of the coronary artery depending upon the focus of development at the time of their participation

It is anticipated that healthy volunteers will undergo non-contrast or contrast-enhanced MRI for evaluating the image quality associated with each acquisition module of the developed technique and motion artifact associated with motion compensation strategy. For subjects receiving contrast, a total dose of up to 0.2 mmol/kg of a gadolinium based contrast agent will be injected intravenously provided all the safety requirements are met.

Subjects undergoing a contrast-enhanced MRI will be screened using the standard clinical protocol to determine whether it is safe to administer contrast. If subjects do not qualify for contrast administration, they may be asked to have a research scan without contrast.

Research MRI results will be compared with clinical diagnostic CT and/or invasive imaging studies for patients who have been evaluated with these exams at Cedars-Sinai Medical Center..

Вмешательства

• Устройство Cardiac MRI
  MRI with/without administration of a contrast agent and beta-blocker based upon the stage of method development, if no contraindications are present.
• Препарат Contrast
  The intravenous gadolinium based contrast agent to be used in this study is Gadavist (up to 0.2 mmol/kg).
• Препарат Beta blocker
  Based upon the focus of the study at the time of the scan, a beta- blocker (metoprolol), in pill form based upon blood pressure and heart rate, may be administered to some subjects to improve the heart's ability to relax and slow the heart rate. The slower heart rate may improve image quality and lessen motion artifact.

Первичные конечные точки

• Plaque to Myocardial Ratio (PMR). [Срок оценки: Day 1]

Вторичные конечные точки (1)

• Stenosis level (patient group only) [Срок оценки: Day 1]

Критерии участия

Inclusion:

• Healthy Volunteers: male or female ≥ 18 years of age with a BMI<30, with no history of cardiovascular disease
• Patients: Medically stable, male or female ≥ 18 years of age who is have not suspected of having or has been diagnosed with coronary artery disease and undergone stenting or bypass surgery

Exclusion:

• Contraindications to MR imaging including mechanically, magnetically, or electrically activated implants, ferromagnetic implants and ferromagnetic foreign bodies, pregnancy.
• Inability to tolerate MR imaging secondary to an inability to hold breath for a short time or have claustrophobia.
• Non-compliant with visit instructions, including following procedure instructions
• Severe allergy to animal dander or animal-instigated asthma
• Specific to gadolinium-based contrast agents: Renal function test does not meet CSMC standard of care MRI contrast protocol requirements (GFR <45ml/min) or previous allergic reaction to gadolinium-based contrast agents.\*
• Volunteers who have had four or more prior previous gadolinium contrast scan

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Cedars-Sinai Medical Center — Los Angeles

Идентификаторы

NCT: NCT03504956 · 45312

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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