Angiogenesis and Fibrosis in Aortic Stenosis
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ClinicalTrials.gov Identifier: NCT01837160 |
Recruitment Status :
Completed
First Posted : April 23, 2013
Last Update Posted : August 30, 2016
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Condition or disease | Intervention/treatment |
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Aortic Stenosis Fibrosis Neovascularization, Pathologic | Procedure: Cardiac MRI scan Radiation: CT-PET scan Procedure: Echocardiogram Radiation: CT-coronary angiogram scan Procedure: Aortic Valve Replacement |

Study Type : | Observational |
Actual Enrollment : | 21 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | The Identification of In Vivo Angiogenesis and Fibrosis in Aortic Stenosis Using Positron Emission Tomography |
Study Start Date : | April 2013 |
Actual Primary Completion Date : | August 2015 |
Actual Study Completion Date : | August 2015 |

Group/Cohort | Intervention/treatment |
---|---|
Healthy Volunteers
10 patients with normal echocardiogram studies and no history of ischaemic heart disease. Patients to recieve CT-PET with fluciclatide, cardiac MRI scan, CT-coronary angiogram and echocardiogram. |
Procedure: Cardiac MRI scan
Cardiac MRI scan with assessment of late gadolinium enhancement and T1 mapping. Radiation: CT-PET scan Computed Tomography / Positron Emission Tomography scan with 18F-fluciclatide tracer. Procedure: Echocardiogram Echocardiography. Radiation: CT-coronary angiogram scan CT-coronary angiogram following CT-PET scan. Standard protocol. |
Moderate Aortic Stenosis (n=10)
Patients with moderate aortic stenosis. Patients are to recieve Cardiac MRI, CT-PET scan, echocardiography and CT-coronary angiogram scan at baseline. They will undergo repeat cardiac MRI scan and echocardiogram at 12 - 24 months. |
Procedure: Cardiac MRI scan
Cardiac MRI scan with assessment of late gadolinium enhancement and T1 mapping. Radiation: CT-PET scan Computed Tomography / Positron Emission Tomography scan with 18F-fluciclatide tracer. Procedure: Echocardiogram Echocardiography. Radiation: CT-coronary angiogram scan CT-coronary angiogram following CT-PET scan. Standard protocol. |
Mild Aortic Stenosis (n=10)
Patients with mild aortic stenosis. Patients are to recieve Cardiac MRI, CT-PET scan, echocardiography and CT-coronary angiogram scan at baseline. They will undergo repeat cardiac MRI scan and echocardiogram at 12 - 24 months. |
Procedure: Cardiac MRI scan
Cardiac MRI scan with assessment of late gadolinium enhancement and T1 mapping. Radiation: CT-PET scan Computed Tomography / Positron Emission Tomography scan with 18F-fluciclatide tracer. Procedure: Echocardiogram Echocardiography. Radiation: CT-coronary angiogram scan CT-coronary angiogram following CT-PET scan. Standard protocol. |
Severe aortic Stenosis (n=10)
Patients with severe aortic stenosis. Patients are to recieve Cardiac MRI, CT-PET scan, echocardiography and CT-coronary angiogram scan at baseline. They will undergo repeat cardiac MRI scan and echocardiogram at 12 - 24 months. |
Procedure: Cardiac MRI scan
Cardiac MRI scan with assessment of late gadolinium enhancement and T1 mapping. Radiation: CT-PET scan Computed Tomography / Positron Emission Tomography scan with 18F-fluciclatide tracer. Procedure: Echocardiogram Echocardiography. Radiation: CT-coronary angiogram scan CT-coronary angiogram following CT-PET scan. Standard protocol. |
Severe Aortic Stenosis for AVR (n=10)
Patients with severe aortic stenosis proceeding to aortic valve replacement. Patients are to recieve Cardiac MRI, CT-PET scan, echocardiography and CT-coronary angiogram scan at baseline. They will undergo a repeat CT-PET scan 3 months after the operation. They will undergo repeat cardiac MRI scan and echocardiogram at 12 months after the operation. |
Procedure: Cardiac MRI scan
Cardiac MRI scan with assessment of late gadolinium enhancement and T1 mapping. Radiation: CT-PET scan Computed Tomography / Positron Emission Tomography scan with 18F-fluciclatide tracer. Procedure: Echocardiogram Echocardiography. Radiation: CT-coronary angiogram scan CT-coronary angiogram following CT-PET scan. Standard protocol. Procedure: Aortic Valve Replacement For AVR (already scheduled prior to enrollment)
Other Name: AVR |
- The mean and maximum standardised uptake values (SUV) of fluciclatide for the myocardium and its correlation with the severity of aortic stenosis determined echocardiographically. [ Time Frame: 1 - 2 years ]
- The mean and maximum standardised uptake values (SUV) of fluciclatide for the myocardium and its correlation with the volume of myocardial fibrosis on magnetic resonance scanning. [ Time Frame: 1 - 2 years ]
- The mean and maximum standardised uptake values (SUV) of fluciclatide in the aortic valve in patients with aortic stenosis [ Time Frame: 1 year ]
- The mean and maximum standardised uptake values (SUV) of fluciclatide in concomitant aortic atheroma [ Time Frame: 1 year ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria
- asymptomatic mild (peak valve velocity of 2-5-3.0 m/s; n=10), moderate (peak valve velocity of 3.0-4.0 m/s; n=10) or severe aortic stenosis (peak valve velocity of >4.0 m/s; n=10) and 10 patients with severe aortic stenosis proceeding to aortic valve replacement.
- Healthy control subjects (n=10) will have no past medical history of ischaemic heart disease or valvular heart disease and have a structurally normal heart on echocardiography.
Exclusion Criteria:
- Atrial fibrillation
- Hepatic failure (Childs-Pugh grade B or C)
- Renal failure (estimated glomerular filtration rate <25 mL/min)
- Women of child-bearing potential
- Contraindication to magnetic resonance imaging
- Inability to undergo scanning
- Ochronosis and those with any form of collagen-vascular disease.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837160
United Kingdom | |
University of Edinburgh | |
Edinburgh, Lothian, United Kingdom, EH16 4TJ |
Study Director: | David E Newby, MBChB PhD | University of Edinburgh | |
Principal Investigator: | William Sa Jenkins, MBChB MRCP | University of Edinburgh |
Responsible Party: | University of Edinburgh |
ClinicalTrials.gov Identifier: | NCT01837160 |
Other Study ID Numbers: |
2012/R/CAR/23 FS/12/84/29814 ( Other Grant/Funding Number: BHF Clinical Research Training Fellowship ) |
First Posted: | April 23, 2013 Key Record Dates |
Last Update Posted: | August 30, 2016 |
Last Verified: | March 2015 |
Angiogenesis Fibrosis Aortic Stenosis Imaging |
CT-PET PET-CT Cardiac MRI |
Aortic Valve Stenosis Fibrosis Constriction, Pathologic Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Anatomical |
Aortic Valve Disease Heart Valve Diseases Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction Metaplasia |