Characterizing Vulnerable Plaques in Non-ST-Elevation Myocardial Infarction using PET-CMR: A Feasibility Study

Characterizing Vulnerable Plaques in Non-ST-Elevation Myocardial Infarction using PET-CMR: A Feasibility Study - Vulnerable plaque imaging in NSTEMI (CULPRIT)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43579

Enrollment

Registered

2015-09-17

Start date

2017-09-05

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

instabiele plaque myocardial infarction

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Prolonged symptoms suspected of cardiac origin (angina pectoris or angina equivalent), and presentation on the cardiac ED 14ng/L) (initial blood sample at presentation or a second sample) * Only patients scheduled for invasive coronary angiography * Age 18 years * 85 years * Mentally competent * Informed written consent

Exclusion criteria

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 (ICA) * Patients requiring invasive coronary angiography (ICA) 200/110 mmHg) * More than mild aortic and mitral valve calcification or stenosis by latest echocardiography * Pregnancy * Breast feeding women * Life expectancy 130 kg or body habitus that does not fit intro the gantry o Renal failure (estimated GFR *30 mL/min/1,73m2) / chronic renal failure stage 4-5 o Known severe allergy to gadolinium contrast agents (patient with mild allergy is eligible for inclusion when pre-medication according to hospital guidelines can be administered)

Design outcomes

Primary

Measure	Time frame
The frequency of coronary vulnerable plaques in patients with NSTEMI as assessed with 18F-NaF-PET-CMR and routine invasive coronary angiography. Vulnerable plaques will be operationalized as present/absent, and if detected, additionally as a count variable, i.e. numbers of vulnerable plaques per patient.	—

Secondary

Measure	Time frame
* The distribution (location) of coronary vulnerable plaques using 18F-NaF-PET and the location of myocardial infarction using CMR at baseline and follow-up (* 6 months). We hypothesize that the hybrid imaging will enable a juxtaposition of the location(s) of vulnerable coronary artery with the presence/location of scar. * The frequency and distribution of systemic (carotid) vulnerable plaques as assessed with 18F-NaF-PET-CMR at baseline and follow-up (* 6 months). * The frequency of clinical systemic arterial events (cerebrovascular accidents (CVA), transient ischemic attacks (TIA, including amaurosis fugax), peripheral arterial embolism, or progressive peripheral occlusive arterial disease peripheral arterial disease) during one year. * Serial serum concentrations of biomarkers of plaque vulnerability and myocardial injury at baseline and follow-up (* 6 months).	—

Measure

Time frame

* The distribution (location) of coronary vulnerable plaques using 18F-NaF-PET and the location of myocardial infarction using CMR at baseline and follow-up (* 6 months). We hypothesize that the hybrid imaging will enable a juxtaposition of the location(s) of vulnerable coronary artery with the presence/location of scar. * The frequency and distribution of systemic (carotid) vulnerable plaques as assessed with 18F-NaF-PET-CMR at baseline and follow-up (* 6 months). * The frequency of clinical systemic arterial events (cerebrovascular accidents (CVA), transient ischemic attacks (TIA, including amaurosis fugax), peripheral arterial embolism, or progressive peripheral occlusive arterial disease peripheral arterial disease) during one year. * Serial serum concentrations of biomarkers of plaque vulnerability and myocardial injury at baseline and follow-up (* 6 months).

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Countries

Netherlands

Outcome results