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

NCT ID: NCT02072850

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 324 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2031-05-01

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.

Detailed Description

Magnetic resonance imaging (MRI) provides detailed insights into soft tissue characteristics and this technique has particular value for imaging patients with acute myocardial infarction (MI). Recent advances in MRI have the potential to reveal new insights into the evolution and functional significance of myocardial injury and repair.

Here, we will study at least 300 consecutive patients with acute ST elevation MI (STEMI) and focus on oedema, scar and bleeding in the heart using MRI in patients managed by emergency percutaneous coronary intervention (PCI). Cardiac MRI scans will be performed at 1.5 Tesla (MAGNETOM, Siemens Healthcare). MRI will be used to assess initial heart function and injury. Myocardial salvage and haemorrhage are prioritised outcomes. Novel MRI methods will also be used to quantify the extent of myocardial jeopardy representing the initial area-at-risk (AAR), and the nature of this injury (strain, haemorrhage). The MRI methods will include T1, T2 and T2* relaxometry (mapping). Secondly, we will assess coronary artery disease severity by angiography and coronary artery function at the time of the heart attack treatment using a pressure-sensitive coronary guidewire (St Jude Medical). This wire can be used instead of the usual coronary wire and can provide information on heart injury, which can be linked in turn to the MRI findings. All of this information will be linked with health outcomes in the longer term.

We hypothesise that myocardial salvage, oedema, haemorrhage, and strain as revealed by MRI, have functional and prognostic significance. In all patients MRI will be performed at baseline (~day 2) and again at 6 months. In a subgroup of 30 patients, MRI will be performed on days <12 hours, and days 2, 7-10 days and 6 months post-MI. A blood and urine sample and quality of life will be obtained at baseline and at 6 months post-MI. Clinical outcomes (e.g. rehospitalisation, death) will be assessed at the end of the study (minimum 1 year) and again during longer term follow-up (minimum 3 years, maximum 20 years) by electronic linkage through central National Health Service (NHS) and government health records in order to determine the long-term prognostic significance of our initial observations with angiography, MRI and the pressure wire. The main statistical analyses will be conducted by an independent trials unit statistician.

Conditions

Acute ST-elevation Myocardial Infarction

Study Design

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

Study Groups

Myocardial infarction

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

Coronary pressure wire

Intervention Type: 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.

Magnetic resonance imaging of the heart

Intervention Type: 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).

Interventions

Coronary pressure wire

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.

Intervention Type: DEVICE

Magnetic resonance imaging of the heart

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).

Intervention Type: OTHER

Other Intervention Names

Pressure wire Certus (St Jude Medical); Cardiac MRI

Eligibility Criteria

Inclusion Criteria

• Acute STEMI

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Siemens Healthcare Diagnostics Inc

INDUSTRY

Sponsor Role: collaborator

British Heart Foundation

OTHER

Sponsor Role: collaborator

NHS National Waiting Times Centre Board

OTHER

Sponsor Role: lead

Responsible Party

Colin Berry

Professor of Cardiology and Imaging

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Colin Berry, MB ChB BSc PhD FRCP FACC

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Locations

Golden Jubilee National Hospital

Clydebank, Dunbartonshire, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 26418191 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29153575 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32689822 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27354423 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30371237 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27699259 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30457480 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30031700 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31168381 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27580675 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30012869 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35272808 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37634958 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38777509 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37821183 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27803036 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27081030 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27043975 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26908408 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26763281 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26261290 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26093923 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27041786 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24835328 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24583294 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23279917 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23248208 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28231914 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29051544 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29242240 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30777200 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32122822 (View on PubMed)

Related Links

http://www.nhsresearchscotland.org.uk/research-in-scotland

Chief Scientist Office, NHS Scotland and Healthscience Scotland

https://www.bhf.org.uk/research

British Heart Foundation

Other Identifiers

Research grant number

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Government health research

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

10/S0703/28

Identifier Type: -

Identifier Source: org_study_id