Angina PectorisNCT02776657
Intracoronary Thrombus Detection by Magnetic Resonance Imaging
A study testing Magnetic Resonance Imaging, Optical Coherence Tomography and Invasive Coronary Angiography in people with Angina Pectoris and Angina, Stable, run by University of Edinburgh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina Pectoris, Angina, Stable, Angina, Unstable
- What is being tested?
- Magnetic Resonance Imaging, Optical Coherence Tomography and Invasive Coronary Angiography
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 14 Jan 2016to 31 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Non-Invasive Assessment of Intracoronary Thrombosis in Patients With Acute Coronary Syndrome and Chronic Stable Angina Using Magnetic Resonance Imaging.
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.
Read the 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.
- Being tested
- Magnetic Resonance Imaging, Optical Coherence Tomography, Invasive Coronary Angiography
- Medical subject headings
- Angina Pectoris, Angina, Stable, Angina, Unstable, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingOther
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.
Optical Coherence TomographyDevice
Participants may undergo Optical Coherence Tomography (OCT) during the angiogram procedure in order to detect thrombus within the coronary arteries.
Invasive Coronary AngiographyProcedure or surgery
This will be performed as part of usual care and does not constitute part of the research project.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (Stable Angina) | Active comparator | 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. Receives: Other: Magnetic Resonance Imaging; Device: Optical Coherence Tomography; Procedure: Invasive Coronary Angiography |
| Cohort 2 (Acute Coronary Syndrome) | Active comparator | 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. Receives: Other: Magnetic Resonance Imaging; Device: Optical Coherence Tomography; Procedure: Invasive Coronary Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of high intensity signals within the coronary arteries on T1 weighted magnetic resonance imaging.
Measured: Within 72 hours prior to angiography
Secondary outcomes (4)
The correlation between high risk plaques as determined on MRI with culprit plaques on invasive angiography in patients with acute coronary syndrome (ACS).
Measured: Through study completion, an average of 1 year
Incidence of intracoronary thrombosis, as detected by magnetic resonance imaging, in patients with stable coronary artery disease.
Measured: Through study completion, an average of 1 year
The change in plaque signal intensity on magnetic resonance imaging at one month following acute coronary syndrome (ACS).
Measured: Baseline and 1 month
The change in plaque signal intensity on magnetic resonance imaging at three months following acute coronary syndrome (ACS).
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study start14 Jan 2016
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mhairi K Doris, MBChB, Principal investigator, University of Edinburgh/NHS LothianDavid E Newby, PhD, Study director, University of Edinburgh/NHS Lothian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776657
- Sponsor's protocol ID
- 2015/0421
- Status last verified
- Jun 2024
- First submitted
- 27 Apr 2016
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Assessment of Intracoronary Thrombosis in Patients With Acute Coronary Syndrome and Chronic Stable Angina Using Magnetic Resonance Imaging.
- ClinicalTrials.gov ID
- NCT02776657
- Acronym / sponsor ID
- 2015/0421
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 14 Jan 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 18 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (Stable Angina) | Active comparator | Other: Magnetic Resonance Imaging, Device: Optical Coherence Tomography, Procedure: Invasive Coronary Angiography20 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. |
| Cohort 2 (Acute Coronary Syndrome) | Active comparator | Other: Magnetic Resonance Imaging, Device: Optical Coherence Tomography, Procedure: Invasive Coronary Angiography20 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
- Planned invasive coronary angiography
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingEach 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. | Other | Cohort 1 (Stable Angina), Cohort 2 (Acute Coronary Syndrome) |
| Optical Coherence TomographyParticipants may undergo Optical Coherence Tomography (OCT) during the angiogram procedure in order to detect thrombus within the coronary arteries. | Device | Cohort 1 (Stable Angina), Cohort 2 (Acute Coronary Syndrome) |
| Invasive Coronary AngiographyThis will be performed as part of usual care and does not constitute part of the research project. | Procedure or surgery | Cohort 1 (Stable Angina), Cohort 2 (Acute Coronary Syndrome) |
Primary outcome
Evidence of high intensity signals within the coronary arteries on T1 weighted magnetic resonance imaging.
Time frame: Within 72 hours prior to angiography
4 secondary outcomes
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
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
The change in plaque signal intensity on magnetic resonance imaging at one month following acute coronary syndrome (ACS).
Time frame: Baseline and 1 month
The change in plaque signal intensity on magnetic resonance imaging at three months following acute coronary syndrome (ACS).
Time frame: Baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mhairi K Doris, MBChB principal investigator
University of Edinburgh/NHS Lothian
David E Newby, PhD study director
University of Edinburgh/NHS Lothian
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging, Optical Coherence Tomography and Invasive Coronary Angiography in people with Angina Pectoris and Angina, Stable, run by University of Edinburgh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of high intensity signals within the coronary arteries on T1 weighted magnetic resonance imaging. (time frame: Within 72 hours prior to angiography). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.