Advanced Cardiac Magnetic Resonance Imaging for Assessment of Obstructive Coronary Artery Disease: ADVOCATE-CMR

Coronary Artery Disease Clinical Trial

— ADVOCATE-CMR  

Official title:

Advanced Cardiac Magnetic Resonance Imaging for Assessment of Obstructive Coronary Artery Disease: ADVOCATE-CMR

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06419894
• Other study ID #: NL84828.015.23
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: June 1, 2033

Study information

• Verified date: May 2024
• Source: Amsterdam UMC, location VUmc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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:

1. 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;

2. 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;

3. 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);

4. Clinical follow-up - 3, 6 months, 1 and 3 years after ICA or revascularization (if performed separately more than 1 day following ICA)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 182
• Est. completion date: June 1, 2033
• Est. primary completion date: June 1, 2033
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• 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

Exclusion criteria:

• 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

• 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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diagnostic accuracies of QP CMR (stress MBF, stress rMBF, MPR and rMPR), ?T1 and B-MORE to detect microvascular dysfunction (MVD), as defined by CFR	Sensitivity, specificity, accuracy, AUC, PPV, NPV	ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Other	Diagnostic accuracy of QP CMR (stress MBF, stress rMBF, MPR and rMPR), ?T1 and B-MORE to differentiate between MVD (as defined by CFR) and 3-vessel obstructive CAD	Sensitivity, specificity, accuracy, AUC, PPV, NPV	ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Other	Change in stress MBF after revascularization	Difference between stress MBF before revascularization (baseline) and after revascularization (in ml/g/min)	ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Other	Change in MPR after revascularization	Difference between MPR before revascularization (baseline) and after revascularization	ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Other	Change in stress T1 mapping after revascularization	Difference between stress T1 mapping before revascularization (baseline) and after revascularization (in ms)	ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Other	Change in ?T1 after revascularization	Difference between ?T1 before revascularization (baseline) and after revascularization	ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Other	Change in B-MORE after revascularization	Difference between B-MORE before revascularization (baseline) and after revascularization (in %)	ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Other	Costs of QP CMR, stress T1 mapping reactivity and OS CMR compared to ICA		CMR and following ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Other	Procedural time of QP CMR, stress T1 mapping reactivity and OS CMR compared to ICA		CMR and following ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Primary	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)	ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Secondary	Diagnostic accuracy of ?T1 to detect obstructive CAD, as defined by FFR	Sensitivity, specificity, accuracy, AUC, PPV, NPV	ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Secondary	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	ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Secondary	Head-to-head comparison of diagnostic accuracies of QP CMR (stress MBF, stress rMBF, MPR, rMPR), ?T1, 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	ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Secondary	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	ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Secondary	Diagnostic accuracy of ?T1 to detect obstructive CAD, as defined by iFR and resting Pd/Pa	Sensitivity, specificity, accuracy, AUC, PPV, NPV	ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Secondary	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	ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Secondary	Head-to-head comparison of diagnostic accuracies of QP CMR (stress MBF, stress rMBF, MPR, rMPR), ?T1, 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	ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Secondary	Relation of stress and rest MBF and rMBF, MPR and rMPR, ?T1 and B-MORE to Seattle Angina Questionnaire (SAQ)-7 Summary score		Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable)
Secondary	Relation of stress and rest MBF and rMBF, MPR and rMPR, ?T1 and B-MORE to SAQ-7 Angina Frequency score		Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable)
Secondary	Relation of stress and rest MBF and rMBF, MPR and rMPR, ?T1 and B-MORE to SAQ-7 Physical Limitation score		Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable)
Secondary	Relation of stress and rest MBF and rMBF, MPR and rMPR, ?T1 and B-MORE to SAQ-7 Quality of Life score		Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable)
Secondary	Relation of stress and rest MBF and rMBF, MPR and rMPR, ?T1 and B-MORE to Rose Dyspnea Scale score		Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable)
Secondary	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	3 months, 6 months, 1 year, 3 years