Angiogenesis and Fibrosis in Myocardial Infarction
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01813045 |
Recruitment Status
:
Completed
First Posted
: March 18, 2013
Last Update Posted
: August 30, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Myocardial Infarction Fibrosis Neovascularization, Pathologic | Procedure: Cardiac MRI scan Radiation: CT-PET scan Radiation: CT-coronary angiogram |

Study Type : | Observational |
Actual Enrollment : | 30 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | The Identification of In Vivo Angiogenesis and Fibrosis in Myocardial Infarction Using Positron Emission Tomography. |
Study Start Date : | April 2013 |
Actual Primary Completion Date : | March 2016 |
Actual Study Completion Date : | March 2016 |

Group/Cohort | Intervention/treatment |
---|---|
Chronic Coronary Occlusion group
We will also recruit 10 patients with an angiographically documented chronic (>6 months) proximal coronary artery occlusion that has not been revascularised but has extensive collateral coronary blood flow. We will perform CT-coronary angiogram, cardiac MRI scan and CT-PET scan. |
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.
Radiation: CT-coronary angiogram
CT-coronary angiogram following CT-PET scan. Standard protocol.
|
MI (non-revascularised)
These patients (n=15) will undergo Cardiac MRI, CT-PET scan and CT-coronary angiogram scan 2 weeks following their myocardial infarction. They will undergo a second CT-PET scan 9 weeks following their myocardial infarction. They will undergo a second cardiac MRI scan 6 - 12 months following their myocardial infarction. |
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.
Radiation: CT-coronary angiogram
CT-coronary angiogram following CT-PET scan. Standard protocol.
|
MI (revascularised)
These patients (n=15) will undergo Cardiac MRI, CT-PET scan and CT-coronary angiogram scan 2 weeks following their myocardial infarction. They will undergo a second CT-PET scan 9 weeks following their myocardial infarction. They will undergo a second cardiac MRI scan 6 - 12 months following their myocardial infarction. |
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.
Radiation: CT-coronary angiogram
CT-coronary angiogram following CT-PET scan. Standard protocol.
|
- The primary outcome is heart function determined by ejection fraction (in %) 6 months following a heart attack. [ Time Frame: 6 - 12 months ]
- Extent of fibrosis (% late gadolinium enhancement) & blood flow 6 months post-MI, and the correlation with integrin expression at 9 weeks (fluciclatide distribution through the myocardium viewed on CTPET images). [ Time Frame: 1 year ]
Biospecimen Retention: Samples Without DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Patients will be recruited if they are >40 years of age and have sustained a recent large (plasma troponin I concentration >10 ng/mL; upper limit of normal 0.05 ng/mL) acute myocardial infarction defined according to the Universal Definition of myocardial infarction [Thygesen et al, 2007].
We will recruit patients with a major epicardial occlusion that has or has not been revascularised with percutaneous coronary intervention (n=15 per group). We will also recruit 10 patients with an angiographically documented chronic (>6 months) proximal coronary artery occlusion that has not been revascularised but has extensive collateral coronary blood flow.
Exclusion Criteria:
- A known critical (≥95%) left main stem coronary artery stenosis
- Continued symptoms of angina at rest or minimal exertion
- Atrial fibrillation
- Hepatic failure (Childs-Pugh grade B or C)
- Renal failure (estimated glomerular filtration rate <25 mL/min)
- Women of child-bearing potential.
- Inability to undergo scanning
- Contraindication to magnetic resonance imaging

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): NCT01813045
United Kingdom | |
University of Edinburgh | |
Edinburgh, Lothian, United Kingdom, EH16 4TJ |
Principal Investigator: | William SA Jenkins, MBChB | University of Edinburgh / NHS Lothian | |
Study Director: | David E Newby, MBChB PhD | University of Edinburgh / NHS Lothian |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Edinburgh |
ClinicalTrials.gov Identifier: | NCT01813045 History of Changes |
Other Study ID Numbers: |
2012/R/CAR/22 FS/12/84/29814 ( Other Grant/Funding Number: BHF Clinical Research Training Fellowship ) |
First Posted: | March 18, 2013 Key Record Dates |
Last Update Posted: | August 30, 2016 |
Last Verified: | March 2015 |
Keywords provided by University of Edinburgh:
Angiogenesis Fibrosis Myocardial Infarction Imaging |
CT-PET PET-CT Cardiac MRI |
Additional relevant MeSH terms:
Fibrosis Infarction Myocardial Infarction Neovascularization, Pathologic Pathologic Processes Ischemia |
Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Metaplasia |