Back to resultsIntracoronary Thrombus Detection by Magnetic Resonance Imaging
Primary Purpose
Angina Pectoris, Angina, Stable, Angina, Unstable
Status
Suspended
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Magnetic Resonance Imaging
Optical Coherence Tomography
Invasive Coronary Angiography
Sponsored by
About this trial
This is an interventional diagnostic trial for Angina Pectoris
Eligibility Criteria
Inclusion Criteria:
- Aged over 18 years
- Previously diagnosed coronary artery disease undergoing elective invasive angiography (Cohort 1) OR
Admitted with Acute Coronary Syndrome (ACS) diagnosed by two of the following criteria;
- Elevation of cardiac biomarkers (high sensitivity troponin I greater than 34ng/l in men and 16ng/l in women).
- Symptoms of myocardial ischaemia
- Electrocardiogram (ECG) changes indicative of acute ischaemia (Cohort 2)
- Planned invasive coronary angiography
Exclusion Criteria:
- Contraindication or inability to undergo MRI scanning
- Renal failure (estimated glomerular filtration rate less than 30millilitres/minute)
- Undergoing Primary Percutaneous Coronary Intervention
- Ongoing myocardial ischaemia or dynamic ECG changes
- Inability to provide informed consent
- Known allergy to gadolinium based contrast
- Women who are pregnant, breastfeeding or of child-bearing potential
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Cohort 1 (Stable Angina)
Cohort 2 (Acute Coronary Syndrome)
Arm Description
20 patients with stable angina planned to undergo elective coronary angiography will be recruited and each participant will undergo magnetic resonance imaging (MRI) prior to invasive coronary angiography. During the angiogram, Optical Coherence Tomography (OCT) may be used to identify thrombus within the coronary arteries.
20 patients diagnosed with acute coronary syndrome will be recruited and each participant will undergo magnetic resonance imaging (MRI) prior to invasive coronary angiography. During the angiogram, Optical Coherence Tomography (OCT) may be used to identify thrombus within the coronary arteries. If thrombus is identified, participants will be asked to undergo a repeat MRI scan at one and three months.
Outcomes
Primary Outcome Measures
Evidence of high intensity signals within the coronary arteries on T1 weighted magnetic resonance imaging.
Secondary Outcome Measures
The correlation between high risk plaques as determined on MRI with culprit plaques on invasive angiography in patients with acute coronary syndrome (ACS).
Incidence of intracoronary thrombosis, as detected by magnetic resonance imaging, in patients with stable coronary artery disease.
The change in plaque signal intensity on magnetic resonance imaging at one month following acute coronary syndrome (ACS).
The change in plaque signal intensity on magnetic resonance imaging at three months following acute coronary syndrome (ACS).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02776657
Brief Title
Intracoronary Thrombus Detection by Magnetic Resonance Imaging
Official Title
Non-Invasive Assessment of Intracoronary Thrombosis in Patients With Acute Coronary Syndrome and Chronic Stable Angina Using Magnetic Resonance Imaging.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Suspended
Study Start Date
June 2016 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
April 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study involves the use of Magnetic Resonance Imaging (MRI) to determine whether blood clots can be identified within the blood vessels supplying blood to the heart in patients with angina and who have recently suffered a heart attack.
Detailed Description
The majority of heart attacks are caused as a result of small blood clots forming within the blood vessels supplying blood to the heart, obstructing blood flow to the heart muscle. Research has also shown that blood clots may form in the blood vessels of the heart without causing a heart attack. At present, blood clots may be identified by techniques used during invasive coronary angiography, but we wish to determine whether a non-invasive test (MRI scanning) can be used to detect small blood clots within the blood vessels supplying blood to the heart muscle.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris, Angina, Stable, Angina, Unstable, Myocardial Infarction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1 (Stable Angina)
Arm Type
Active Comparator
Arm Description
20 patients with stable angina planned to undergo elective coronary angiography will be recruited and each participant will undergo magnetic resonance imaging (MRI) prior to invasive coronary angiography. During the angiogram, Optical Coherence Tomography (OCT) may be used to identify thrombus within the coronary arteries.
Arm Title
Cohort 2 (Acute Coronary Syndrome)
Arm Type
Active Comparator
Arm Description
20 patients diagnosed with acute coronary syndrome will be recruited and each participant will undergo magnetic resonance imaging (MRI) prior to invasive coronary angiography. During the angiogram, Optical Coherence Tomography (OCT) may be used to identify thrombus within the coronary arteries. If thrombus is identified, participants will be asked to undergo a repeat MRI scan at one and three months.
Intervention Type
Other
Intervention Name(s)
Magnetic Resonance Imaging
Intervention Description
Each participant will undergo at least one MRI scan. A small number will be asked to undergo repeat MRI scanning at one and three months following the initial scan.
Intervention Type
Device
Intervention Name(s)
Optical Coherence Tomography
Intervention Description
Participants may undergo Optical Coherence Tomography (OCT) during the angiogram procedure in order to detect thrombus within the coronary arteries.
Intervention Type
Procedure
Intervention Name(s)
Invasive Coronary Angiography
Intervention Description
This will be performed as part of usual care and does not constitute part of the research project.
Primary Outcome Measure Information:
Title
Evidence of high intensity signals within the coronary arteries on T1 weighted magnetic resonance imaging.
Time Frame
Within 72 hours prior to angiography
Secondary Outcome Measure Information:
Title
The correlation between high risk plaques as determined on MRI with culprit plaques on invasive angiography in patients with acute coronary syndrome (ACS).
Time Frame
Through study completion, an average of 1 year
Title
Incidence of intracoronary thrombosis, as detected by magnetic resonance imaging, in patients with stable coronary artery disease.
Time Frame
Through study completion, an average of 1 year
Title
The change in plaque signal intensity on magnetic resonance imaging at one month following acute coronary syndrome (ACS).
Time Frame
Baseline and 1 month
Title
The change in plaque signal intensity on magnetic resonance imaging at three months following acute coronary syndrome (ACS).
Time Frame
Baseline and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged over 18 years
Previously diagnosed coronary artery disease undergoing elective invasive angiography (Cohort 1) OR
Admitted with Acute Coronary Syndrome (ACS) diagnosed by two of the following criteria;
Elevation of cardiac biomarkers (high sensitivity troponin I greater than 34ng/l in men and 16ng/l in women).
Symptoms of myocardial ischaemia
Electrocardiogram (ECG) changes indicative of acute ischaemia (Cohort 2)
Planned invasive coronary angiography
Exclusion Criteria:
Contraindication or inability to undergo MRI scanning
Renal failure (estimated glomerular filtration rate less than 30millilitres/minute)
Undergoing Primary Percutaneous Coronary Intervention
Ongoing myocardial ischaemia or dynamic ECG changes
Inability to provide informed consent
Known allergy to gadolinium based contrast
Women who are pregnant, breastfeeding or of child-bearing potential
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mhairi K Doris, MBChB
Organizational Affiliation
University of Edinburgh/NHS Lothian
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David E Newby, PhD
Organizational Affiliation
University of Edinburgh/NHS Lothian
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Intracoronary Thrombus Detection by Magnetic Resonance Imaging
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