Detection and Significance of Heart Injury in ST Elevation Myocardial Infarction.

NCT02072850 | Active Not Recruiting

• 3 other identifiers: 10/S0703/28Research grant numberGovernment health research
• Study Type: observational
• Target: 324
• Locations: 1 country
• Sites: 1

Brief Summary

Heart imaging with magnetic resonance imaging (MRI) provides detailed insights into heart function and injury. The nature and significance of heart injury after a heart attack is incompletely understood. We propose a 'natural history' study of heart attack injury using contemporary MRI methods. In a large hospital in the West of Scotland, heart attack patients will be invited to have at least two MRI scans and also continue with life-long follow-up. The results from the MRI scans will be assessed with all of the other clinical information obtained at the time of the heart attack and during follow-up. The results of our study should provide new insights into heart attack injury and these results should help improve how heart attack patients should be treated.

Conditions

Acute ST-elevation Myocardial Infarction

Keywords

Myocardial infarction; Primary percutaneous coronary intervention (PCI); Thrombolysis; Rescue PCI; Electrocardiogram; Magnetic resonance imaging; Area-at-risk; Myocardial salvage; Infarct size; Pressure wire; Coronary thermodilution; Coronary microvascular function; Index of microvascular resistance; Heart failure; Prognosis

Outcome Measures

Primary Outcomes (1)

• Myocardial salvage

  Myocardial salvage (% left ventricular volume) was defined as the difference between the initial jeopardised area-at-risk revealed by T2-weighted MRI (1.5 Tesla, Siemens Healthcare) at baseline and final infarct size revealed by contrast-enhanced MRI at 6 months on the same MRI scanner.

  Baseline and 6 months after date of index hospitalisation for STEMI

Secondary Outcomes (20)

• Myocardial salvage index

  Baseline and 6 months

• Final infarct size

  MRI scan at 6 months after index hospitalisation

• Myocardial haemorrhage

  Baseline MRI scan

• Microvascular obstruction

  Baseline MRI scan

• First pass MVO

  Baseline MRI

Study Arms (1)

Myocardial infarction

Patients presenting with acute-ST elevation myocardial infarction referred for emergency invasive management by primary or rescue percutaneous coronary intervention.

Device: Coronary pressure wire; Other: Magnetic resonance imaging of the heart

Interventions

Coronary pressure wire DEVICE

Guidewire-based coronary pressure- and temperature recordings (coronary thermodilution) with and without hyperaemia induced by intravenous administration of adenosine (140 ug/kg/min) in patients with acute ST-elevation myocardial infarction treated by emergency PCI.

Also known as: Pressure wire Certus (St Jude Medical)

Myocardial infarction

Magnetic resonance imaging of the heart OTHER

Cardiac magnetic resonance imaging (MRI) with gadolinium contrast imaging at baseline (\~ day 2) and 6 months (all participants) and in 30 subjects at 4 time-points (\< 12 hours, days 2, 7-10 and at 6 months).

Also known as: Cardiac MRI

Myocardial infarction

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of ST-elevation myocardial infarction (STEMI).

You may qualify if:

• Acute STEMI

You may not qualify if:

• Major systemic illness (e.g. cancer limiting survival \< 6 months);
• Metallic implant (e.g. cochlear implant);
• Metallic foreign body
• Pregnancy.

Sponsors & Collaborators

• NHS National Waiting Times Centre Board: lead
• Siemens Healthcare Diagnostics Inc: collaborator
• British Heart Foundation: collaborator

Study Sites (1)

Golden Jubilee National Hospital

Clydebank, Dunbartonshire, G84 4DY, United Kingdom

Location

Related Publications (32)

• Ahmed N, Layland J, Carrick D, Petrie MC, McEntegart M, Eteiba H, Hood S, Lindsay M, Watkins S, Davie A, Mahrous A, Carberry J, Teng V, McConnachie A, Curzen N, Oldroyd KG, Berry C. Safety of guidewire-based measurement of fractional flow reserve and the index of microvascular resistance using intravenous adenosine in patients with acute or recent myocardial infarction. Int J Cardiol. 2016 Jan 1;202:305-10. doi: 10.1016/j.ijcard.2015.09.014. Epub 2015 Sep 18.

  PMID: 26418191 BACKGROUND

• Carberry J, Carrick D, Haig C, Ahmed N, Mordi I, McEntegart M, Petrie MC, Eteiba H, Hood S, Watkins S, Lindsay M, Davie A, Mahrous A, Ford I, Sattar N, Welsh P, Radjenovic A, Oldroyd KG, Berry C. Persistent Iron Within the Infarct Core After ST-Segment Elevation Myocardial Infarction: Implications for Left Ventricular Remodeling and Health Outcomes. JACC Cardiovasc Imaging. 2018 Sep;11(9):1248-1256. doi: 10.1016/j.jcmg.2017.08.027. Epub 2017 Nov 15.

  PMID: 29153575 BACKGROUND

• Bulluck H, Carberry J, Carrick D, McEntegart M, Petrie MC, Eteiba H, Hood S, Watkins S, Lindsay M, Mahrous A, Ford I, Oldroyd KG, Berry C. Redefining Adverse and Reverse Left Ventricular Remodeling by Cardiovascular Magnetic Resonance Following ST-Segment-Elevation Myocardial Infarction and Their Implications on Long-Term Prognosis. Circ Cardiovasc Imaging. 2020 Jul;13(7):e009937. doi: 10.1161/CIRCIMAGING.119.009937. Epub 2020 Jul 21.

  PMID: 32689822 BACKGROUND

• Carberry J, Carrick D, Haig C, Rauhalammi SM, Ahmed N, Mordi I, McEntegart M, Petrie MC, Eteiba H, Hood S, Watkins S, Lindsay M, Davie A, Mahrous A, Ford I, Sattar N, Welsh P, Radjenovic A, Oldroyd KG, Berry C. Remote Zone Extracellular Volume and Left Ventricular Remodeling in Survivors of ST-Elevation Myocardial Infarction. Hypertension. 2016 Aug;68(2):385-91. doi: 10.1161/HYPERTENSIONAHA.116.07222. Epub 2016 Jun 27.

  PMID: 27354423 BACKGROUND

• Yew SN, Carrick D, Corcoran D, Ahmed N, Carberry J, Teng Yue May V, McEntegart M, Petrie MC, Eteiba H, Lindsay M, Hood S, Watkins S, Davie A, Mahrous A, Mordi I, Ford I, Oldroyd KG, Berry C. Coronary Thermodilution Waveforms After Acute Reperfused ST-Segment-Elevation Myocardial Infarction: Relation to Microvascular Obstruction and Prognosis. J Am Heart Assoc. 2018 Aug 7;7(15):e008957. doi: 10.1161/JAHA.118.008957.

  PMID: 30371237 BACKGROUND

• Carrick D, Haig C, Carberry J, May VTY, McCartney P, Welsh P, Ahmed N, McEntegart M, Petrie MC, Eteiba H, Lindsay M, Hood S, Watkins S, Mahrous A, Rauhalammi SM, Mordi I, Ford I, Radjenovic A, Sattar N, Oldroyd KG, Berry C. Microvascular resistance of the culprit coronary artery in acute ST-elevation myocardial infarction. JCI Insight. 2016 May 5;1(6):e85768. doi: 10.1172/jci.insight.85768.

  PMID: 27699259 BACKGROUND

• Mangion K, Carrick D, Carberry J, Mahrous A, McComb C, Oldroyd KG, Eteiba H, Lindsay M, McEntegart M, Hood S, Petrie MC, Watkins S, Davie A, Zhong X, Epstein FH, Haig CE, Berry C. Circumferential Strain Predicts Major Adverse Cardiovascular Events Following an Acute ST-Segment-Elevation Myocardial Infarction. Radiology. 2019 Feb;290(2):329-337. doi: 10.1148/radiol.2018181253. Epub 2018 Nov 20.

  PMID: 30457480 BACKGROUND

• Haig C, Carrick D, Carberry J, Mangion K, Maznyczka A, Wetherall K, McEntegart M, Petrie MC, Eteiba H, Lindsay M, Hood S, Watkins S, Davie A, Mahrous A, Mordi I, Ahmed N, Teng Yue May V, Ford I, Radjenovic A, Welsh P, Sattar N, Oldroyd KG, Berry C. Current Smoking and Prognosis After Acute ST-Segment Elevation Myocardial Infarction: New Pathophysiological Insights. JACC Cardiovasc Imaging. 2019 Jun;12(6):993-1003. doi: 10.1016/j.jcmg.2018.05.022. Epub 2018 Jul 18.

  PMID: 30031700 BACKGROUND

• Maznyczka AM, Carrick D, Carberry J, Mangion K, McEntegart M, Petrie MC, Eteiba H, Lindsay M, Hood S, Watkins S, Davie A, Mahrous A, Ford I, Welsh P, Sattar N, Oldroyd KG, Berry C. Sex-based associations with microvascular injury and outcomes after ST-segment elevation myocardial infarction. Open Heart. 2019 Apr 29;6(1):e000979. doi: 10.1136/openhrt-2018-000979. eCollection 2019.

  PMID: 31168381 BACKGROUND

• Ahmed N, Carberry J, Teng V, Carrick D, Berry C. Risk assessment in patients with an acute ST-elevation myocardial infarction. J Comp Eff Res. 2016 Nov;5(6):581-593. doi: 10.2217/cer-2016-0017. Epub 2016 Sep 1.

  PMID: 27580675 BACKGROUND

• Carrick D, Haig C, Maznyczka AM, Carberry J, Mangion K, Ahmed N, Yue May VT, McEntegart M, Petrie MC, Eteiba H, Lindsay M, Hood S, Watkins S, Davie A, Mahrous A, Mordi I, Ford I, Radjenovic A, Welsh P, Sattar N, Wetherall K, Oldroyd KG, Berry C. Hypertension, Microvascular Pathology, and Prognosis After an Acute Myocardial Infarction. Hypertension. 2018 Sep;72(3):720-730. doi: 10.1161/HYPERTENSIONAHA.117.10786.

  PMID: 30012869 BACKGROUND

• Bulluck H, Carberry J, Carrick D, McCartney PJ, Maznyczka AM, Greenwood JP, Maredia N, Chowdhary S, Gershlick AH, Appleby C, Cotton JM, Wragg A, Curzen N, McEntegart M, Petrie MC, Eteiba H, Watkins S, Lindsay M, Mahrous A, Oldroyd KG, Berry C. A Noncontrast CMR Risk Score for Long-Term Risk Stratification in Reperfused ST-Segment Elevation Myocardial Infarction. JACC Cardiovasc Imaging. 2022 Mar;15(3):431-440. doi: 10.1016/j.jcmg.2021.08.006. Epub 2022 Jan 12.

  PMID: 35272808 BACKGROUND

• Reindl M, Stiermaier T, Lechner I, Tiller C, Holzknecht M, Fink P, Mayr A, Klug G, Feistritzer HJ, Delewi R, Hirsch A, Carberry J, Carrick D, Bauer A, Metzler B, Nijveldt R, Thiele H, Berry C, Eitel I, Reinstadler SJ. Infarct severity and outcomes in ST-elevation myocardial infarction patients without standard modifiable risk factors - A multicenter cardiac magnetic resonance study. Eur J Intern Med. 2024 Jan;119:78-83. doi: 10.1016/j.ejim.2023.08.013. Epub 2023 Aug 25.

  PMID: 37634958 BACKGROUND

• Lechner I, Reindl M, Stiermaier T, Tiller C, Holzknecht M, Oberhollenzer F, von der Emde S, Mayr A, Feistritzer HJ, Carberry J, Carrick D, Bauer A, Thiele H, Berry C, Eitel I, Metzler B, Reinstadler SJ. Clinical Outcomes Associated With Various Microvascular Injury Patterns Identified by CMR After STEMI. J Am Coll Cardiol. 2024 May 28;83(21):2052-2062. doi: 10.1016/j.jacc.2024.03.408.

  PMID: 38777509 BACKGROUND

• El Farissi M, Zimmermann FM, De Maria GL, van Royen N, van Leeuwen MAH, Carrick D, Carberry J, Wijnbergen IF, Konijnenberg LSF, Hoole SP, Marin F, Fineschi M, Pijls NHJ, Oldroyd KG, Banning AP, Berry C, Fearon WF. The Index of Microcirculatory Resistance After Primary PCI: A Pooled Analysis of Individual Patient Data. JACC Cardiovasc Interv. 2023 Oct 9;16(19):2383-2392. doi: 10.1016/j.jcin.2023.08.030.

  PMID: 37821183 BACKGROUND

• Carrick D, Haig C, Ahmed N, Carberry J, Yue May VT, McEntegart M, Petrie MC, Eteiba H, Lindsay M, Hood S, Watkins S, Davie A, Mahrous A, Mordi I, Ford I, Radjenovic A, Oldroyd KG, Berry C. Comparative Prognostic Utility of Indexes of Microvascular Function Alone or in Combination in Patients With an Acute ST-Segment-Elevation Myocardial Infarction. Circulation. 2016 Dec 6;134(23):1833-1847. doi: 10.1161/CIRCULATIONAHA.116.022603. Epub 2016 Nov 1.

  PMID: 27803036 BACKGROUND

• Berry C, Carrick D, Haig C, Oldroyd KG. "Waves of Edema" Seem Implausible. J Am Coll Cardiol. 2016 Apr 19;67(15):1868-1869. doi: 10.1016/j.jacc.2015.11.073. No abstract available.

  PMID: 27081030 BACKGROUND

• Mangion K, Corcoran D, Carrick D, Berry C. New perspectives on the role of cardiac magnetic resonance imaging to evaluate myocardial salvage and myocardial hemorrhage after acute reperfused ST-elevation myocardial infarction. Expert Rev Cardiovasc Ther. 2016 Jul;14(7):843-54. doi: 10.1586/14779072.2016.1173544. Epub 2016 Apr 26.

  PMID: 27043975 BACKGROUND

• Carrick D, Haig C, Ahmed N, Rauhalammi S, Clerfond G, Carberry J, Mordi I, McEntegart M, Petrie MC, Eteiba H, Hood S, Watkins S, Lindsay MM, Mahrous A, Welsh P, Sattar N, Ford I, Oldroyd KG, Radjenovic A, Berry C. Temporal Evolution of Myocardial Hemorrhage and Edema in Patients After Acute ST-Segment Elevation Myocardial Infarction: Pathophysiological Insights and Clinical Implications. J Am Heart Assoc. 2016 Feb 23;5(2):e002834. doi: 10.1161/JAHA.115.002834.

  PMID: 26908408 BACKGROUND

• Carrick D, Haig C, Ahmed N, McEntegart M, Petrie MC, Eteiba H, Hood S, Watkins S, Lindsay MM, Davie A, Mahrous A, Mordi I, Rauhalammi S, Sattar N, Welsh P, Radjenovic A, Ford I, Oldroyd KG, Berry C. Myocardial Hemorrhage After Acute Reperfused ST-Segment-Elevation Myocardial Infarction: Relation to Microvascular Obstruction and Prognostic Significance. Circ Cardiovasc Imaging. 2016 Jan;9(1):e004148. doi: 10.1161/CIRCIMAGING.115.004148.

  PMID: 26763281 BACKGROUND

• Carrick D, Haig C, Rauhalammi S, Ahmed N, Mordi I, McEntegart M, Petrie MC, Eteiba H, Hood S, Watkins S, Lindsay M, Mahrous A, Ford I, Tzemos N, Sattar N, Welsh P, Radjenovic A, Oldroyd KG, Berry C. Prognostic significance of infarct core pathology revealed by quantitative non-contrast in comparison with contrast cardiac magnetic resonance imaging in reperfused ST-elevation myocardial infarction survivors. Eur Heart J. 2016 Apr 1;37(13):1044-59. doi: 10.1093/eurheartj/ehv372. Epub 2015 Aug 10.

  PMID: 26261290 BACKGROUND

• Carrick D, Haig C, Rauhalammi S, Ahmed N, Mordi I, McEntegart M, Petrie MC, Eteiba H, Lindsay M, Watkins S, Hood S, Davie A, Mahrous A, Sattar N, Welsh P, Tzemos N, Radjenovic A, Ford I, Oldroyd KG, Berry C. Pathophysiology of LV Remodeling in Survivors of STEMI: Inflammation, Remote Myocardium, and Prognosis. JACC Cardiovasc Imaging. 2015 Jul;8(7):779-89. doi: 10.1016/j.jcmg.2015.03.007. Epub 2015 Jun 17.

  PMID: 26093923 BACKGROUND

• Gao H, Carrick D, Berry C, Griffith BE, Luo X. Dynamic finite-strain modelling of the human left ventricle in health and disease using an immersed boundary-finite element method. IMA J Appl Math. 2014 Oct;79(5):978-1010. doi: 10.1093/imamat/hxu029. Epub 2014 Jul 1.

  PMID: 27041786 BACKGROUND

• Layland J, Carrick D, Lee M, Oldroyd K, Berry C. Adenosine: physiology, pharmacology, and clinical applications. JACC Cardiovasc Interv. 2014 Jun;7(6):581-91. doi: 10.1016/j.jcin.2014.02.009. Epub 2014 May 14.

  PMID: 24835328 BACKGROUND

• Carrick D, Oldroyd KG, McEntegart M, Haig C, Petrie MC, Eteiba H, Hood S, Owens C, Watkins S, Layland J, Lindsay M, Peat E, Rae A, Behan M, Sood A, Hillis WS, Mordi I, Mahrous A, Ahmed N, Wilson R, Lasalle L, Genereux P, Ford I, Berry C. A randomized trial of deferred stenting versus immediate stenting to prevent no- or slow-reflow in acute ST-segment elevation myocardial infarction (DEFER-STEMI). J Am Coll Cardiol. 2014 May 27;63(20):2088-2098. doi: 10.1016/j.jacc.2014.02.530. Epub 2014 Feb 27.

  PMID: 24583294 BACKGROUND

• Ahmed N, Carrick D, Layland J, Oldroyd KG, Berry C. The role of cardiac magnetic resonance imaging (MRI) in acute myocardial infarction (AMI). Heart Lung Circ. 2013 Apr;22(4):243-55. doi: 10.1016/j.hlc.2012.11.016. Epub 2012 Dec 29.

  PMID: 23279917 BACKGROUND

• Carrick D, Berry C. Prognostic importance of myocardial infarct characteristics. Eur Heart J Cardiovasc Imaging. 2013 Apr;14(4):313-5. doi: 10.1093/ehjci/jes296. Epub 2012 Dec 17. No abstract available.

  PMID: 23248208 BACKGROUND

• Berry C, McEntegart M, Petrie MC, Eteiba H, Lindsay M, Hood S, Watkins S, Davie A, Carrick D, Payne AR, McGeoch RJ, Oldroyd KG. Meta-Analysis of the Index of Microvascular Resistance in Acute STEMI Using Incomplete Data. JACC Cardiovasc Interv. 2017 Feb 27;10(4):421-422. doi: 10.1016/j.jcin.2016.12.268. No abstract available.

  PMID: 28231914 BACKGROUND

• Gao H, Mangion K, Carrick D, Husmeier D, Luo X, Berry C. Estimating prognosis in patients with acute myocardial infarction using personalized computational heart models. Sci Rep. 2017 Oct 19;7(1):13527. doi: 10.1038/s41598-017-13635-2.

  PMID: 29051544 BACKGROUND

• Carberry J, Carrick D, Haig C, Ahmed N, Mordi I, McEntegart M, Petrie MC, Eteiba H, Hood S, Watkins S, Lindsay M, Davie A, Mahrous A, Ford I, Sattar N, Welsh P, Radjenovic A, Oldroyd KG, Berry C. Persistence of Infarct Zone T2 Hyperintensity at 6 Months After Acute ST-Segment-Elevation Myocardial Infarction: Incidence, Pathophysiology, and Prognostic Implications. Circ Cardiovasc Imaging. 2017 Dec;10(12):e006586. doi: 10.1161/CIRCIMAGING.117.006586.

  PMID: 29242240 BACKGROUND

• Mangion K, Carrick D, Clerfond G, Rush C, McComb C, Oldroyd KG, Petrie MC, Eteiba H, Lindsay M, McEntegart M, Hood S, Watkins S, Davie A, Auger DA, Zhong X, Epstein FH, Haig CE, Berry C. Predictors of segmental myocardial functional recovery in patients after an acute ST-Elevation myocardial infarction. Eur J Radiol. 2019 Mar;112:121-129. doi: 10.1016/j.ejrad.2019.01.010. Epub 2019 Jan 14.

  PMID: 30777200 BACKGROUND

• Maznyczka AM, Carrick D, Oldroyd KG, James-Rae G, McCartney P, Greenwood JP, Good R, McEntegart M, Eteiba H, Lindsay MM, Cotton JM, Petrie MC, Berry C. Thermodilution-derived temperature recovery time: a novel predictor of microvascular reperfusion and prognosis after myocardial infarction. EuroIntervention. 2021 Jun 25;17(3):220-228. doi: 10.4244/EIJ-D-19-00904.

  PMID: 32122822 BACKGROUND

Related Links

• Chief Scientist Office, NHS Scotland and Healthscience Scotland
• British Heart Foundation

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples have been archived.

MeSH Terms

Conditions

Myocardial Infarction; Heart Failure

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Colin Berry, MB ChB BSc PhD FRCP FACC

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology and Imaging

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: February 27, 2014
• Study Start: May 1, 2011
• Primary Completion: November 1, 2012
• Study Completion (Estimated): May 1, 2031
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

GB (1)