TerminatedNCT02563964CULPRITUpdated Mar 12, 2020

Vulnerable Plaque Imaging in NSTEMI

An observational study in Myocardial Infarction and Myocardial Ischemia, sponsored by Maastricht University Medical Center. Terminated at 1 site in Netherlands. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-03-12.

Sponsored by Maastricht University Medical Center · Observational

Why this study was terminated

Logistical reasons and slow recruitment

Study type: Observational
Model: Case-control
Time perspective: Prospective
Enrollment: 10
Ages: 18 Years to 85 Years
Sex: All

Study 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:

Compare coronary vulnerable plaque detection between 18F-NaF PET/CMR and invasive coronary angiography,
Investigate the correlation of coronary vulnerable plaques using 18F-NaF PET with myocardial infarction using CMR, both at baseline and during follow-up,
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
Examine the relation between vulnerable plaques and plasma biomarkers.

Conditions studied

Myocardial Infarction
Myocardial Ischemia

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Keywords

Myocardial infarction
vulnerable plaque
Positron emission tomography (PET)
Cardiac magnetic resonance imaging (CMR)
Biomarkers

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 10 is below the median of 500 across 983 observational studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

Thirty-three patients, 18-85 years old and admitted with non-ST elevation myocardial infarction (NSTEMI). After informed consent, patients wil receive standard, guideline-based clinical care that includes invasive coronary angiography. Plasma biomaker will be sampled serially, and a comprehensive Sodium 18F-Fluoride Positron Emission Tomography/Cardiac Magnetic Resonance imaging (18F-NaF PET/CMR) will be performed at baseline (\<72 hours) and at 6 months, or earlier when patients suffer recurrent myocardial infarction \< 6months. Patients will be followed for one year during regular outpatient clinic visits.

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

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

Study design

Observational model: Case-control
Time perspective: Prospective
Enrollment: 10 participants (actual)
Target follow-up: 1 Year
Patient registry: Yes
Biospecimen retention: Samples without dna

What researchers measure

Primary outcomes

The frequency of coronary vulnerable plaques in non-ST-elevation myocardial infarction (NSTEMI) using 18Fluoride Sodium-Fluoride (18F-NaF) Positron Emission Tomography/Cardiac Magnetic Resonance (PET/CMR).
Time frame: 0 to 6 months
The frequency of coronary vulnerable plaques in NSTEMI using routine invasive coronary angiography.
Time frame: 0 to 6 months

Secondary outcomes

The location of vulnerable plaques within the coronary arteries using 18F-NaF PET at baseline and follow-up.
Time frame: 0 to 6 months
Based on the AHA 17-segment model, the segmental location of MI using CMR at baseline and follow-up.
Time frame: 0 to 6 months
The frequency of systemic vulnerable plaques as assessed with 18F-NaF PET/CMR at baseline and follow-up.
Time frame: 0 to 6 months
Serial serum concentrations of biomarkers of plaque vulnerability and myocardial injury at baseline and follow-up.
Time frame: 0 to 6 months

Study locations

1 site

Maastricht University Medical Center
Maastricht, Limburg 6202 AZ, Netherlands

References and documents

Publications

Libby P, Theroux P. Pathophysiology of coronary artery disease. Circulation. 2005 Jun 28;111(25):3481-8. doi: 10.1161/CIRCULATIONAHA.105.537878. PubMed 15983262 ↗
Virmani R, Kolodgie FD, Burke AP, Farb A, Schwartz SM. Lessons from sudden coronary death: a comprehensive morphological classification scheme for atherosclerotic lesions. Arterioscler Thromb Vasc Biol. 2000 May;20(5):1262-75. doi: 10.1161/01.atv.20.5.1262. No abstract available. PubMed 10807742 ↗
Cutlip DE, Chhabra AG, Baim DS, Chauhan MS, Marulkar S, Massaro J, Bakhai A, Cohen DJ, Kuntz RE, Ho KK. Beyond restenosis: five-year clinical outcomes from second-generation coronary stent trials. Circulation. 2004 Sep 7;110(10):1226-30. doi: 10.1161/01.CIR.0000140721.27004.4B. Epub 2004 Aug 30. PubMed 15337693 ↗
Glaser R, Selzer F, Faxon DP, Laskey WK, Cohen HA, Slater J, Detre KM, Wilensky RL. Clinical progression of incidental, asymptomatic lesions discovered during culprit vessel coronary intervention. Circulation. 2005 Jan 18;111(2):143-9. doi: 10.1161/01.CIR.0000150335.01285.12. Epub 2004 Dec 27. PubMed 15623544 ↗
Kim HW, Klem I, Shah DJ, Wu E, Meyers SN, Parker MA, Crowley AL, Bonow RO, Judd RM, Kim RJ. Unrecognized non-Q-wave myocardial infarction: prevalence and prognostic significance in patients with suspected coronary disease. PLoS Med. 2009 Apr 21;6(4):e1000057. doi: 10.1371/journal.pmed.1000057. Epub 2009 Apr 21. PubMed 19381280 ↗
Kato K, Yonetsu T, Kim SJ, Xing L, Lee H, McNulty I, Yeh RW, Sakhuja R, Zhang S, Uemura S, Yu B, Mizuno K, Jang IK. Nonculprit plaques in patients with acute coronary syndromes have more vulnerable features compared with those with non-acute coronary syndromes: a 3-vessel optical coherence tomography study. Circ Cardiovasc Imaging. 2012 Jul;5(4):433-40. doi: 10.1161/CIRCIMAGING.112.973701. Epub 2012 Jun 7. PubMed 22679059 ↗
Stone GW, Maehara A, Lansky AJ, de Bruyne B, Cristea E, Mintz GS, Mehran R, McPherson J, Farhat N, Marso SP, Parise H, Templin B, White R, Zhang Z, Serruys PW; PROSPECT Investigators. A prospective natural-history study of coronary atherosclerosis. N Engl J Med. 2011 Jan 20;364(3):226-35. doi: 10.1056/NEJMoa1002358. Erratum In: N Engl J Med. 2011 Nov 24;365(21):2040. PubMed 21247313 ↗
Joshi NV, Vesey AT, Williams MC, Shah AS, Calvert PA, Craighead FH, Yeoh SE, Wallace W, Salter D, Fletcher AM, van Beek EJ, Flapan AD, Uren NG, Behan MW, Cruden NL, Mills NL, Fox KA, Rudd JH, Dweck MR, Newby DE. 18F-fluoride positron emission tomography for identification of ruptured and high-risk coronary atherosclerotic plaques: a prospective clinical trial. Lancet. 2014 Feb 22;383(9918):705-13. doi: 10.1016/S0140-6736(13)61754-7. Epub 2013 Nov 11. PubMed 24224999 ↗
Dweck MR, Chow MW, Joshi NV, Williams MC, Jones C, Fletcher AM, Richardson H, White A, McKillop G, van Beek EJ, Boon NA, Rudd JH, Newby DE. Coronary arterial 18F-sodium fluoride uptake: a novel marker of plaque biology. J Am Coll Cardiol. 2012 Apr 24;59(17):1539-48. doi: 10.1016/j.jacc.2011.12.037. PubMed 22516444 ↗
Kim RJ, Chen EL, Lima JA, Judd RM. Myocardial Gd-DTPA kinetics determine MRI contrast enhancement and reflect the extent and severity of myocardial injury after acute reperfused infarction. Circulation. 1996 Dec 15;94(12):3318-26. doi: 10.1161/01.cir.94.12.3318. PubMed 8989146 ↗
Kwee RM, van Oostenbrugge RJ, Mess WH, Prins MH, van der Geest RJ, ter Berg JW, Franke CL, Korten AG, Meems BJ, van Engelshoven JM, Wildberger JE, Kooi ME. MRI of carotid atherosclerosis to identify TIA and stroke patients who are at risk of a recurrence. J Magn Reson Imaging. 2013 May;37(5):1189-94. doi: 10.1002/jmri.23918. Epub 2012 Nov 16. PubMed 23166040 ↗
Ambrose JA, Winters SL, Stern A, Eng A, Teichholz LE, Gorlin R, Fuster V. Angiographic morphology and the pathogenesis of unstable angina pectoris. J Am Coll Cardiol. 1985 Mar;5(3):609-16. doi: 10.1016/s0735-1097(85)80384-3. PubMed 3973257 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02563964
Lead sponsor: Maastricht University Medical Center
Responsible party: Sponsor
First posted: Sep 30, 2015
Start date: Sep 1, 2017
Primary completion: Mar 10, 2020
Completion: Mar 10, 2020
Last update: Mar 12, 2020

Study contacts

Joachim Wildberger, MD, PhD

principal investigator · Maastricht University Medical Center

Harry J. Crijns, MD, PhD

principal investigator · Maastricht University Medical Center

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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