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

NCT06419894 | Not Yet Recruiting DMC

• 1 other identifier: NL84828.015.23
• Study Type: observational
• Target: 182
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Coronary Artery Disease

Keywords

Stress perfusion cardiac magnetic resonance; Quantitative perfusion; Stress T1 mapping reactivity; Oxygen-sensitive cardiac magnetic resonance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Diagnostic accuracy of ΔT1 to detect obstructive CAD, as defined by FFR

  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

  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

  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

  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

  ICA + hemodynamic measurements within 6 weeks of the initial CMR scan

Other Outcomes (9)

• Diagnostic accuracies of QP CMR (stress MBF, stress rMBF, MPR and rMPR), ΔT1 and B-MORE to detect microvascular dysfunction (MVD), as defined by CFR

  ICA + hemodynamic measurements within 6 weeks of the initial CMR scan

• Diagnostic accuracy of QP CMR (stress MBF, stress rMBF, MPR and rMPR), ΔT1 and B-MORE to differentiate between MVD (as defined by CFR) and 3-vessel obstructive CAD

  ICA + hemodynamic measurements within 6 weeks of the initial CMR scan

• Change in stress MBF after revascularization

  ICA + hemodynamic measurements within 6 weeks of the initial CMR scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Leader

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 17, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): June 1, 2033
• Study Completion (Estimated): June 1, 2033
• Last Updated: November 13, 2024

Record last verified: 2024-11