Vulnerable Plaque Imaging in NSTEMI

NCT ID: NCT02563964

Last Updated: 2020-03-12

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2020-03-10

Brief Summary

Myocardial infarction (MI) frequently recurs after non-ST elevation MI (NSTEMI) that may be related to insufficient vulnerable plaque identification using invasive coronary angiography. Furthermore, the natural behaviour of vulnerable plaques in NSTEMI over time and their relation with biomarkers need further exploration. More accurate identification and assessing long-term behaviour of vulnerable plaques may improve therapeutic strategies and clinical outcome. The investigators hypothesize that fully integrated 18Fluoride Sodium-Fluoride (18F-NaF) Positron Emission Tomography/Cardiac Magnetic Resonance imaging (PET/CMR) increases the ability to detect vulnerable plaques as compared to coronary angiography.

This prospective study in 33 consecutive patients with NSTEMI aims to:

1. Compare coronary vulnerable plaque detection between 18F-NaF PET/CMR and invasive coronary angiography,

2. Investigate the correlation of coronary vulnerable plaques using 18F-NaF PET with myocardial infarction using CMR, both at baseline and during follow-up,

3. Examine systemic arterial 18F-NaF-uptake using PET/CMR and their relation with systemic events (cerebrovascular accidents, transient ischemic attacks, or peripheral arterial disease), and

4. Examine the relation between vulnerable plaques and plasma biomarkers.

Conditions

Myocardial Infarction; Myocardial Ischemia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Prolonged symptoms suspected of cardiac origin (angina pectoris or angina equivalent), and presentation on the cardiac emergency department <24 hours after symptom onset
• Elevated levels of high-sensitivity troponin T (>14ng/L; initial blood sample at presentation or a second sample 3 hours after presentation)
• Only patients scheduled for invasive coronary angiography
• Age 18 years - 85 years
• Mentally competent
• Informed written consent

Exclusion Criteria

• Conservatively managed patients who are not scheduled for invasive coronary angiography
• Refractory angina or on-going severe ischemia requiring immediate invasive coronary angiography
• Patients requiring invasive coronary angiography < 24 hours after admission
• Hemodynamic instability and cardiogenic shock (mean arterial pressure < 60 mmHg)
• Severe heart failure (Killip Class ≥ III)
• ST elevation myocardial infarction (ST-elevation in 2 contiguous leads: ≥0.2mV in men or ≥0.15 mV in women in leads V2-V3 and/or ≥0.1 mV in other leads or new left bundle branch block)
• Chest pain highly suggestive of non-cardiac origin (as judged by the cardiac emergency department physician/cardiologist):
• (Suspicion of) acute aortic dissection, acute pulmonary embolism, acute peri-myocarditis
• Life threatening arrhythmias on the cardiac emergency department or prior to presentation (sustained ventricular tachycardia, repetitive non-sustained ventricular tachycardia, ventricular fibrillation, sino-artial or atrio-ventricular block)
• Atrial fibrillation with ventricular rate ≥100 beats per minute (bpm)
• Tachycardia (≥100/bpm)
• Angina pectoris secondary to anaemia (<5.6 mmol/L), untreated hyperthyroidism, or severe hypertension (>200/110 mmHg)
• More than mild aortic and mitral valve calcification or stenosis by latest echocardiography
• Pregnancy
• Breast feeding women
• Life expectancy <2 years (malignancy, etc.)
• Refusal of data storage until 15 years after end of study
• Participation in another investigational study that has not reached its primary endpoint
• Contraindications to cardiac magnetic resonance imaging

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joachim Wildberger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Harry J. Crijns, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Countries

Netherlands

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Other Identifiers

NL51875.068.14 / METC 152007

Identifier Type: -

Identifier Source: org_study_id