Cardiovascular Diseases Clinical Trial
— TICKEROfficial title:
The Interrogation of the Cardiomyopathy of Chronic Kidney Disease With advancEd caRdiac Imaging
Verified date | February 2022 |
Source | NHS Greater Glasgow and Clyde |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Patients with kidney failure have a much higher risk of heart disease compared to people of the same age without kidney failure. The reason for this is not fully understood. In this project we will use Cardiac MRI (CMR), which is a very detailed scan of the heart and blood vessels, to try to better understand the cardiovascular changes that occur in kidney failure. We will perform CMR scans in 30 patients before and after dialysis (a treatment for patients with kidney failure) to see whether dialysis changes the heart muscle. The same patients will also undergo another type of heart scan, called a CT scan. This will allow us to compare the pictures from the 2 different types of scan to help us better understand any damage to the heart muscle that is present. Finally, we will test a new way to measure hardening of blood vessels on CMR. These three studies will help us to better understand the heart and blood vessel changes that happen in kidney failure. This research will also be useful for patients without kidney failure. We hope to be able to use it in the future to see which new treatments might be able to reduce the risk of heart disease in patients with kidney failure.
Status | Terminated |
Enrollment | 28 |
Est. completion date | August 5, 2020 |
Est. primary completion date | August 5, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 100 Years |
Eligibility | Inclusion Criteria: 1. Age 40-100 years at time of recruitment. 2. Established on regular day-time, hospital-based haemodialysis for >6 months. 3. History of recurrent fluid overload, defined as a mean of >1.5 litres fluid removal per dialysis session from an average of 3 consecutive sessions. 4. No previous clinical diagnosis of heart failure, or if previous clinical diagnosis of heart failure then must have preserved left ventricular function (ejection fraction >50% or reported as 'normal' or (similar)) on most recent transthoracic echo. 5. Ability to comply with study procedures, including ability to lie flat for up to 1 hour. 6. Ability to give informed consent. Exclusion Criteria: 1. Standard contra-indications to MRI, including the presence of certain metallic objects in the body (e.g. non-MRI compatible cardiac devices, previous cranial surgery with ferromagnetic clips, metal fragments in eye, etc.) and severe claustrophobia. 2. Known allergy to iodinated radiological contrast. 3. Asthma (unless previous CT with contrast administration within the past 12 months without adverse effect). 4. Pregnancy, lactation or women of child-bearing potential not willing to use highly effective contraception for the duration of the study. 5. Any other reason considered by a study physician to make the subject inappropriate for inclusion. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Queen Elizabeth University Hospital | Glasgow |
Lead Sponsor | Collaborator |
---|---|
NHS Greater Glasgow and Clyde |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Part 1A: Myocardial native T1 in response to changing fluid status | Change in myocardial native T1 mapping (MOLLI) on cardiac MRI at visit 2, compared to visit 1, following removal of excess fluid by ultrafiltration. | 24 hours | |
Primary | Part 1B: Measurement of myocardial extracellular volume by CT (ECV-CT) | Comparison between myocardial extracellular volume on contrast-enhanced CT and myocardial native T1 times measured on cardiac MRI. | Baseline | |
Primary | Part 1C: Vascular calcification on MRI | Comparison between Cardiac MRI and CT to detect the presence or absence of vascular calcification within the thoracic aorta at the level of the right pulmonary artery (PA). | Baseline |
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