Coronary Artery DiseaseNCT01236807
MR INFORM - MR Perfusion Imaging to Guide Management of Patients With Stable Coronary Artery Disease
A study testing MR perfusion guidance and FFR guidance in people with Coronary Artery Disease and Stable Angina, run by King's College London at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine if MR Perfusion Imaging is non-inferior to coronary angiography with measurement of Fractional Flow Reserve (FFR) in guiding management of patients with stable chest pain. All patients will undergo an MR Perfusion Imaging test. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Stable Angina, Myocardial Ischaemia
- What is being tested?
- MR perfusion guidance and FFR guidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 915 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2010to Dec 2016
- 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
- Angina pectoris CCS class II and III and either
- ≥2 cardiovascular risk factors
- or positive exercise treadmill test
- Signed written informed consent
- age: at least 18 years
Who cannot join
- contraindication to MR
- contraindication to adenosine infusion
- EF≤ 30%
- inability to lie supine for 60 minutes
- previous Coronary Artery Bypass Grafts
- revascularization within the previous 6 months
Show all 10Show fewer
- cardiac arrhythmias (atrial fibrillation, >20 ectopic beats/min)
- poor renal function (eGFR <30ml/min)
- body weight > 140kg or waist perimeter > 95cm
- known allergy to contrast media
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MR INFORM - a Randomized Non-inferiority Multicenter Trial Comparing MR Perfusion Imaging and Fractional Flow Reserve (FFR) to Guide Management of Patients With Stable Coronary Artery Disease
The purpose of this study is to determine if MR Perfusion Imaging is non-inferior to coronary angiography with measurement of Fractional Flow Reserve (FFR) in guiding management of patients with stable chest pain.
- All patients will undergo an MR Perfusion Imaging test.
- Further management will be guided by the result of the cardiac MRI in half of the patients (chosen by random).
- The other half will undergo coronary angiography with measurement of FFR. The result of this test alone will guide their further management. The result of the initial MR Perfusion test will not be available to the treating doctors of this group.
- All patients will receive optimal medical therapy (OMT)
- All patients will undergo follow-up to find out if they have any relevant heart related events.
- Conditions
- Coronary Artery Disease, Stable Angina, Myocardial Ischaemia
- Being tested
- MR perfusion guidance, FFR guidance
- Keywords
- Adenosine, Magnetic Resonance Imaging, MR perfusion, Fractional Flow Reserve, Myocardial, FFR, Pressure wire, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis
- Medical subject headings
- Coronary Artery Disease, Angina, Stable, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR perfusion guidanceProcedure or surgery
Coronary revascularization guided by MR perfusion imaging
FFR guidanceProcedure or surgery
Coronary revascularization guided by invasive angiography and FFR
| Study group | Role | What they receive |
|---|---|---|
| MR Inform | Active comparator | Management guided by the result of the MR perfusion scan. Possible intervention: coronary artery revascularization. Receives: Procedure: MR perfusion guidance |
| FFR Inform | Active comparator | Management guided by the result of FFR measurement. Possible intervention: coronary artery revascularization. Receives: Procedure: FFR guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of major adverse cardiac events (MACE)
Composite of all cause death, myocardial infarction and repeat revascularisation.
Measured: 1year
Secondary outcomes (5)
Individual MACE
individual components as defined above
Measured: 1 year
Other adverse events
need for revascularization after initial treatment within 1 year
Measured: 1 year
Course of symptoms (angina, breathlessness)
CCS class, NYHA class
Measured: 1 year
Cost comparison
Costs related to MR- and FFR-guided selection for revascularisation
Measured: 1 year
changes in LV volumes and function
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionAug 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by King's College LondonThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 915 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Bayer
- Responsible party
- Principal investigator, Eike Nagel, King's College London
- Investigators
- Eike Nagel, MD, PhD, Principal investigator, Goethe University Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236807
- Sponsor's protocol ID
- MR INFORM-10
- Status last verified
- Jun 2022
- First submitted
- 8 Nov 2010
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hussain ST, Paul M, Plein S, McCann GP, Shah AM, Marber MS, Chiribiri A, Morton G, Redwood S, MacCarthy P, Schuster A, Ishida M, Westwood MA, Perera D, Nagel E. Design and rationale of the MR-INFORM study: stress perfusion cardiovascular magnetic resonance imaging to guide the management of patients with stable coronary artery disease. J Cardiovasc Magn Reson. 2012 Sep 19;14(1):65. doi: 10.1186/1532-429X-14-65.
PubMed 22992411Nagel E, Berry C. Magnetic Resonance Perfusion or Fractional Flow Reserve in Coronary Disease. Reply. N Engl J Med. 2019 Dec 5;381(23):2277-2278. doi: 10.1056/NEJMc1913968. No abstract available.
PubMed 31801003Nagel E, Greenwood JP, McCann GP, Bettencourt N, Shah AM, Hussain ST, Perera D, Plein S, Bucciarelli-Ducci C, Paul M, Westwood MA, Marber M, Richter WS, Puntmann VO, Schwenke C, Schulz-Menger J, Das R, Wong J, Hausenloy DJ, Steen H, Berry C; MR-INFORM Investigators. Magnetic Resonance Perfusion or Fractional Flow Reserve in Coronary Disease. N Engl J Med. 2019 Jun 20;380(25):2418-2428. doi: 10.1056/NEJMoa1716734.
PubMed 31216398
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR INFORM - a Randomized Non-inferiority Multicenter Trial Comparing MR Perfusion Imaging and Fractional Flow Reserve (FFR) to Guide Management of Patients With Stable Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01236807
- Acronym / sponsor ID
- MR INFORM-10
- Conditions
- Coronary Artery Disease, Stable Angina, Myocardial Ischaemia
- Keywords
- Adenosine, Magnetic Resonance Imaging, MR perfusion, Fractional Flow Reserve, Myocardial, FFR, Pressure wire, Coronary Disease, Heart Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 915 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Bayer
- Study start
- Dec 2010
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Nov 2010 (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.
The purpose of this study is to determine if MR Perfusion Imaging is non-inferior to coronary angiography with measurement of Fractional Flow Reserve (FFR) in guiding management of patients with stable chest pain.
- All patients will undergo an MR Perfusion Imaging test.
- Further management will be guided by the result of the cardiac MRI in half of the patients (chosen by random).
- The other half will undergo coronary angiography with measurement of FFR. The result of this test alone will guide their further management. The result of the initial MR Perfusion test will not be available to the treating doctors of this group.
- All patients will receive optimal medical therapy (OMT)
- All patients will undergo follow-up to find out if they have any relevant heart related events.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MR Inform | Active comparator | Procedure: MR perfusion guidanceManagement guided by the result of the MR perfusion scan. Possible intervention: coronary artery revascularization. |
| FFR Inform | Active comparator | Procedure: FFR guidanceManagement guided by the result of FFR measurement. Possible intervention: coronary artery revascularization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Angina pectoris CCS class II and III and either
- ≥2 cardiovascular risk factors
- or positive exercise treadmill test
- Signed written informed consent
- age: at least 18 years
Key exclusion criteria (10 listed)
- contraindication to MR
- contraindication to adenosine infusion
- EF≤ 30%
- inability to lie supine for 60 minutes
- previous Coronary Artery Bypass Grafts
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 |
|---|---|---|
| MR perfusion guidanceCoronary revascularization guided by MR perfusion imaging | Procedure or surgery | MR Inform |
| FFR guidanceCoronary revascularization guided by invasive angiography and FFR | Procedure or surgery | FFR Inform |
Primary outcome
Occurence of major adverse cardiac events (MACE)
Time frame: 1year
Composite of all cause death, myocardial infarction and repeat revascularisation.
5 secondary outcomes
Individual MACE
Time frame: 1 year
Other adverse events
Time frame: 1 year
Course of symptoms (angina, breathlessness)
Time frame: 1 year
Cost comparison
Time frame: 1 year
changes in LV volumes and function
Time frame: 1 year
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 24 Jun 2022.
- Background: PubMed 22992411Hussain ST, Paul M, Plein S, McCann GP, Shah AM, Marber MS, Chiribiri A, Morton G, Redwood S, MacCarthy P, Schuster A, Ishida M, Westwood MA, Perera D, Nagel E. Design and rationale of the MR-INFORM study: stress perfusion cardiovascular magnetic resonance imaging to guide the management of patients with stable coronary artery disease. J Cardiovasc Magn Reson. 2012 Sep 19;14(1):65. doi: 10.1186/1532-429X-14-65.
- Background: PubMed 31801003Nagel E, Berry C. Magnetic Resonance Perfusion or Fractional Flow Reserve in Coronary Disease. Reply. N Engl J Med. 2019 Dec 5;381(23):2277-2278. doi: 10.1056/NEJMc1913968. No abstract available.
- Results publication: PubMed 31216398Nagel E, Greenwood JP, McCann GP, Bettencourt N, Shah AM, Hussain ST, Perera D, Plein S, Bucciarelli-Ducci C, Paul M, Westwood MA, Marber M, Richter WS, Puntmann VO, Schwenke C, Schulz-Menger J, Das R, Wong J, Hausenloy DJ, Steen H, Berry C; MR-INFORM Investigators. Magnetic Resonance Perfusion or Fractional Flow Reserve in Coronary Disease. N Engl J Med. 2019 Jun 20;380(25):2418-2428. doi: 10.1056/NEJMoa1716734.
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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.
Eike Nagel, MD, PhD principal investigator
Goethe University Frankfurt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR perfusion guidance and FFR guidance in people with Coronary Artery Disease and Stable Angina, run by King's College London at 1 site in United Kingdom.
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 5 inclusion and 10 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 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Occurence of major adverse cardiac events (MACE) (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01236807, which also lists 3 linked publications.
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 24 Jun 2022.