Coronary Artery DiseaseADVOCATE-CMRNCT06419894
Advanced Cardiac Magnetic Resonance Imaging for Assessment of Obstructive Coronary Artery Disease: ADVOCATE-CMR
An observational study of Coronary Artery Disease, run by Amsterdam UMC, location VUmc.
Trial summary
Stress perfusion cardiovascular magnetic resonance (CMR) imaging is an established non-invasive imaging test for detection of obstructive coronary artery disease (CAD). Fully automated quantitative perfusion CMR (QP CMR) is a new technical advancement, which offers measurement of myocardial blood flow in CMR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 182 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Jun 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: 182 symptomatic patients with suspected obstructive CAD (without a previous CAD history), scheduled for invasive coronary angiography according to the decision of the treating clinician.
Who may be able to join
- Suspected obstructive coronary artery disease
- No documented prior history of coronary artery disease
- Clinical referral for invasive coronary angiography according to the referring clinician's decision
- Competent adult (age ≥18 years)
- Signed informed consent
Who cannot join
- Acute coronary syndrome
- History of coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting surgery)
- History of coronary artery disease or acute coronary syndrome (myocardial infarction, unstable angina)
- Use of sildenafil or dipyridamole that cannot be terminated
- Pregnancy or lactation
- Allergic reaction to iodized contrast
Show all 10Show fewer
- Concurrent or prior (within last 30 days) participation in other research studies using interventional drugs
- Extensive comorbidities (i.e. cancer, other severe chronic diseases)
- Contraindication for cardiac magnetic resonance with gadolinium-based contrast agent (including severe claustrophobia, magnetic resonance unsafe implants/devices or MR conditional devices not suitable for 3T scanner, severe renal failure with estimated glomerular filtration rate<30 mL/min/1,73 m2, known hypersensitivity for gadolinium-based contrast agent)
- Contraindications for adenosine usage (including hypersensitivity to adenosine/dipyridamole/regadenoson, second or third degree atrio-ventricular block, sick sinus syndrome, sinus bradycardia (heart rate <40 bpm), long QT syndrome, severe hypertension (> 220/120 mmHg), systolic blood pressure <90mmHg, concomitant use of dipyridamole, severe asthma or severe chronic obstructive pulmonary disease)
About this study
Stress perfusion cardiovascular magnetic resonance (CMR) imaging is an established non-invasive imaging test for detection of obstructive coronary artery disease (CAD). Fully automated quantitative perfusion CMR (QP CMR) is a new technical advancement, which offers measurement of myocardial blood flow in CMR. Additionally, recent innovations have introduced various contrast-agent-free methods for CAD assessment, such as stress T1 mapping reactivity (∆T1) and oxygen-sensitive CMR (OS CMR). These methods might eliminate the necessity for contrast administration in clinical practice, simplifying, reducing time, invasiveness and costs in evaluating patients with suspected obstructive CAD. The ADVOCATE-CMR study aims to validate QP CMR, ∆T1 and OS CMR imaging against invasive fractional flow reserve (FFR) for detection of obstructive CAD. The study also aims to head-to-head compare the diagnostic accuracy of these CMR techniques with the conventional visual assessment of stress perfusion CMR and to correlate them to short- and long-term clinical outcomes.
Read the detailed description
Study design: Single-center, observational, prospective, cross-sectional cohort study performed at the Amsterdam University Medical Centers - Location VUmc.
Study population: 182 symptomatic patients with suspected obstructive CAD (without a previous CAD history), scheduled for invasive coronary angiography (ICA) according to the decision of the treating clinician.
Methods:
- CMR image acquisition prior to clinically scheduled ICA, using the following pulse sequences: cine imaging, OS-CMR with breathing maneuvers, adenosine-stress and rest T1 mapping, adenosine-stress and rest QP-CMR, late gadolinium enhancement;
- Fractional flow reserve (FFR), instantaneous wave-free ratio (iFR), ratio between proximal and distal coronary pressures over entire resting cycle period (Pd/Pa ratio), coronary flow reserve (CFR) and index of microcircular resistance (IMR) in all main coronary arteries during ICA;
- Follow-up CMR according to the abovementioned protocol 3 months after ICA (or 3 months after revascularization, if performed separately more than 1 day following ICA);
- Clinical follow-up - 3, 6 months, 1 and 3 years after ICA or revascularization (if performed separately more than 1 day following ICA)
- Conditions
- Coronary Artery Disease
- Keywords
- Stress perfusion cardiac magnetic resonance, Quantitative perfusion, Stress T1 mapping reactivity, Oxygen-sensitive cardiac magnetic resonance
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of QP CMR (stress myocardial blood flow [MBF], stress relative MBF [rMBF], myocardial perfusion reserve [MPR] and relative MPR [rMPR]) to detect obstructive CAD, as defined by FFR
Sensitivity, specificity, accuracy, area under the curve (AUC), positive predictive value (PPV), negative predictive value (NPV)
Measured: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Secondary outcomes (13)
Diagnostic accuracy of ΔT1 to detect obstructive CAD, as defined by FFR
Sensitivity, specificity, accuracy, AUC, PPV, NPV
Measured: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Diagnostic accuracy of OS CMR (breathing-induced myocardial oxygenation reserve; B-MORE) to detect obstructive CAD, as defined by FFR
Sensitivity, specificity, accuracy, AUC, PPV, NPV
Measured: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Head-to-head comparison of diagnostic accuracies of QP CMR (stress MBF, stress rMBF, MPR, rMPR), ΔT1, OS CMR (B-MORE) and conventional visual assessment of GBCA-based first pass perfusion imaging to detect obstructive CAD, as defined by FFR
Sensitivity, specificity, accuracy, AUC, PPV, NPV
Measured: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Diagnostic accuracy of QP CMR (stress MBF, stress rMBF, MPR and rMPR) to detect obstructive CAD, as defined by iFR and resting Pd/Pa
Sensitivity, specificity, accuracy, AUC, PPV, NPV
Measured: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Diagnostic accuracy of ΔT1 to detect obstructive CAD, as defined by iFR and resting Pd/Pa
Sensitivity, specificity, accuracy, AUC, PPV, NPV
Measured: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Diagnostic accuracy of OS CMR (B-MORE) to detect obstructive CAD, as defined by iFR and resting Pd/Pa
Sensitivity, specificity, accuracy, AUC, PPV, NPV
Measured: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Head-to-head comparison of diagnostic accuracies of QP CMR (stress MBF, stress rMBF, MPR, rMPR), ΔT1, OS CMR (B-MORE) and conventional visual assessment of first pass perfusion imaging to detect obstructive CAD, as defined by iFR and resting Pd/Pa
Sensitivity, specificity, accuracy, AUC, PPV, NPV
Measured: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Relation of stress and rest MBF and rMBF, MPR and rMPR, ΔT1 and B-MORE to Seattle Angina Questionnaire (SAQ)-7 Summary score
Measured: Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable)
Relation of stress and rest MBF and rMBF, MPR and rMPR, ΔT1 and B-MORE to SAQ-7 Angina Frequency score
Measured: Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable)
Relation of stress and rest MBF and rMBF, MPR and rMPR, ΔT1 and B-MORE to SAQ-7 Physical Limitation score
Measured: Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable)
Relation of stress and rest MBF and rMBF, MPR and rMPR, ΔT1 and B-MORE to SAQ-7 Quality of Life score
Measured: Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable)
Relation of stress and rest MBF and rMBF, MPR and rMPR, ΔT1 and B-MORE to Rose Dyspnea Scale score
Measured: Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable)
Prognostic value of QP CMR (stress MBF, stress rMBF, MPR and rMPR), stress T1 mapping reactivity and OS CMR (B-MORE)
- Composite of cardiovascular (CV) death (death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, stroke, CV procedures, CV hemorrhage, other CV causes), myocardial infarction (according ESC/ACCF/AHA/WHF 4th Universal Definition of Myocardial Infarction), ischemia-driven coronary revascularization (all coronary revascularization performed in the context of myocardial infarction and those for worsening symptoms in combination with evidence of myocardial ischemia) or stroke (acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction);
- Composite of myocardial infarction or ischemia-driven coronary revascularization;
- Composite of cardiovascular death, stroke or myocardial infarction;
- Myocardial infarction;
- Ischemia-driven coronary revascularization;
- Stroke;
- Death from any cause;
- CV death
Measured: 3 months, 6 months, 1 year, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Jun 2033 (estimated)
- Study completion1 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonia Borodzicz-Jazdzyk, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419894
- Sponsor's protocol ID
- NL84828.015.23
- Acronym
- ADVOCATE-CMR
- Status last verified
- Nov 2024
- First submitted
- 3 May 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Cardiac Magnetic Resonance Imaging for Assessment of Obstructive Coronary Artery Disease: ADVOCATE-CMR
- ClinicalTrials.gov ID
- NCT06419894
- Acronym / sponsor ID
- ADVOCATE-CMR / NL84828.015.23
- Conditions
- Coronary Artery Disease
- Keywords
- Stress perfusion cardiac magnetic resonance, Quantitative perfusion, Stress T1 mapping reactivity, Oxygen-sensitive cardiac magnetic resonance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Jun 2033 (estimated)
- Study completion
- 1 Jun 2033 (estimated)
- First posted
- 17 May 2024 (actual)
- 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.
Stress perfusion cardiovascular magnetic resonance (CMR) imaging is an established non-invasive imaging test for detection of obstructive coronary artery disease (CAD). Fully automated quantitative perfusion CMR (QP CMR) is a new technical advancement, which offers measurement of myocardial blood flow in CMR. Additionally, recent innovations have introduced various contrast-agent-free methods for CAD assessment, such as stress T1 mapping reactivity (∆T1) and oxygen-sensitive CMR (OS CMR). These methods might eliminate the necessity for contrast administration in clinical practice, simplifying, reducing time, invasiveness and costs in evaluating patients with suspected obstructive CAD. The ADVOCATE-CMR study aims to validate QP CMR, ∆T1 and OS CMR imaging against invasive fractional flow reserve (FFR) for detection of obstructive CAD. The study also aims to head-to-head compare the diagnostic accuracy of these CMR techniques with the conventional visual assessment of stress perfusion CMR and to correlate them to short- and long-term clinical outcomes.
Detailed description
Study design: Single-center, observational, prospective, cross-sectional cohort study performed at the Amsterdam University Medical Centers - Location VUmc.
Study population: 182 symptomatic patients with suspected obstructive CAD (without a previous CAD history), scheduled for invasive coronary angiography (ICA) according to the decision of the treating clinician.
Methods:
- CMR image acquisition prior to clinically scheduled ICA, using the following pulse sequences: cine imaging, OS-CMR with breathing maneuvers, adenosine-stress and rest T1 mapping, adenosine-stress and rest QP-CMR, late gadolinium enhancement;
- Fractional flow reserve (FFR), instantaneous wave-free ratio (iFR), ratio between proximal and distal coronary pressures over entire resting cycle period (Pd/Pa ratio), coronary flow reserve (CFR) and index of microcircular resistance (IMR) in all main coronary arteries during ICA;
- Follow-up CMR according to the abovementioned protocol 3 months after ICA (or 3 months after revascularization, if performed separately more than 1 day following ICA);
- Clinical follow-up - 3, 6 months, 1 and 3 years after ICA or revascularization (if performed separately more than 1 day following ICA)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 182 symptomatic patients with suspected obstructive CAD (without a previous CAD history), scheduled for invasive coronary angiography according to the decision of the treating clinician.
Key inclusion criteria (5 listed)
- Suspected obstructive coronary artery disease
- No documented prior history of coronary artery disease
- Clinical referral for invasive coronary angiography according to the referring clinician's decision
- Competent adult (age ≥18 years)
- Signed informed consent
Key exclusion criteria (10 listed)
- Acute coronary syndrome
- History of coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting surgery)
- History of coronary artery disease or acute coronary syndrome (myocardial infarction, unstable angina)
- Use of sildenafil or dipyridamole that cannot be terminated
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy of QP CMR (stress myocardial blood flow [MBF], stress relative MBF [rMBF], myocardial perfusion reserve [MPR] and relative MPR [rMPR]) to detect obstructive CAD, as defined by FFR
Time frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Sensitivity, specificity, accuracy, area under the curve (AUC), positive predictive value (PPV), negative predictive value (NPV)
13 secondary outcomes
Diagnostic accuracy of ΔT1 to detect obstructive CAD, as defined by FFR
Time frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Diagnostic accuracy of OS CMR (breathing-induced myocardial oxygenation reserve; B-MORE) to detect obstructive CAD, as defined by FFR
Time frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Head-to-head comparison of diagnostic accuracies of QP CMR (stress MBF, stress rMBF, MPR, rMPR), ΔT1, OS CMR (B-MORE) and conventional visual assessment of GBCA-based first pass perfusion imaging to detect obstructive CAD, as defined by FFR
Time frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Diagnostic accuracy of QP CMR (stress MBF, stress rMBF, MPR and rMPR) to detect obstructive CAD, as defined by iFR and resting Pd/Pa
Time frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Diagnostic accuracy of ΔT1 to detect obstructive CAD, as defined by iFR and resting Pd/Pa
Time frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Diagnostic accuracy of OS CMR (B-MORE) to detect obstructive CAD, as defined by iFR and resting Pd/Pa
Time frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Head-to-head comparison of diagnostic accuracies of QP CMR (stress MBF, stress rMBF, MPR, rMPR), ΔT1, OS CMR (B-MORE) and conventional visual assessment of first pass perfusion imaging to detect obstructive CAD, as defined by iFR and resting Pd/Pa
Time frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Relation of stress and rest MBF and rMBF, MPR and rMPR, ΔT1 and B-MORE to Seattle Angina Questionnaire (SAQ)-7 Summary score
Time frame: Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable)
Relation of stress and rest MBF and rMBF, MPR and rMPR, ΔT1 and B-MORE to SAQ-7 Angina Frequency score
Time frame: Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable)
Relation of stress and rest MBF and rMBF, MPR and rMPR, ΔT1 and B-MORE to SAQ-7 Physical Limitation score
Time frame: Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable)
Relation of stress and rest MBF and rMBF, MPR and rMPR, ΔT1 and B-MORE to SAQ-7 Quality of Life score
Time frame: Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable)
Relation of stress and rest MBF and rMBF, MPR and rMPR, ΔT1 and B-MORE to Rose Dyspnea Scale score
Time frame: Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable)
Prognostic value of QP CMR (stress MBF, stress rMBF, MPR and rMPR), stress T1 mapping reactivity and OS CMR (B-MORE)
Time frame: 3 months, 6 months, 1 year, 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Amsterdam UMC, location VUmc.
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: opening soon, as of the sponsor's last update on 13 Nov 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?
This study is still under way. Results are not available in the source record yet.
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?
Diagnostic accuracy of QP CMR (stress myocardial blood flow [MBF], stress relative MBF [rMBF], myocardial perfusion reserve [MPR] and relative MPR [rMPR]) to detect obstructive CAD, as defined by FFR (time frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan). 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 13 Nov 2024.