Prognosis of Subjects With Unexplainable Precordial Deep T-wave Inversion Without Wall Thickness> 15mm
Morphological and Functional Changes and Prognosis of Subjects With Unexplainable Precordial Deep T-wave Inversion Without Apical Wall Thickness> 15mm
1 other identifier
observational
100
1 country
1
Brief Summary
The investigators sought to evaluate the morphological and functional changes and prognosis of participants with unexplainable precordial deep T-wave inversion on ECG and with apical thickness less than 15mm. The conduction of this study was largely due to the increased clinical requirement, which reflected the increased awareness among physicians of missed AHCM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 23, 2016
CompletedFirst Posted
Study publicly available on registry
February 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedApril 11, 2017
April 1, 2017
9.9 years
February 23, 2016
April 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All cause mortality
one year
Secondary Outcomes (1)
apical hypertrophic cardiomyopathy
one year
Eligibility Criteria
subjects with unexplainable precordial deep T-wave inversion on ECG and with apical thickness less than 15mm
You may qualify if:
- Standard 12-lead electrocardiography showing deep T-wave inversion, most prominent in the anterolateral leads (V3-V5 leads) with the negative T wave voltage ≥5mm.
- Without evidence of coronary artery disease, or diameter stenosis ≥50% in one or more coronary vessels.
- Asymmetrical LV hypertrophy confined to the LV apex below the papillary muscle level; end-diastolic apical wall thickness \<15mm with the apical to basal posterior wall thickness ratio \<1.5.
You may not qualify if:
- Subjects who were not in sinus rhythm;
- Patients with T-wave inversion in ≤ 2 contiguous leads, concomitant bundle branch block or QRS\>80 ms or QTC\>440 ms were excluded.
- Blood pressure ≥140/90mmHg.
- Severe valvular lesion, pericardial disease, cardiac tumor, immunological or metabolic disease involving heart.
- History of cardiac surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospitallead
- Beijing Chao Yang Hospitalcollaborator
- Beijing Anzhen Hospitalcollaborator
- Peking Union Medical College Hospitalcollaborator
- Xuanwu Hospital, Beijingcollaborator
Study Sites (1)
Fuwai Hospital
Beijing, Beijing Municipality, 100037, China
Related Publications (8)
Gersh BJ, Maron BJ, Bonow RO, Dearani JA, Fifer MA, Link MS, Naidu SS, Nishimura RA, Ommen SR, Rakowski H, Seidman CE, Towbin JA, Udelson JE, Yancy CW; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; American Society of Echocardiography; American Society of Nuclear Cardiology; Heart Failure Society of America; Heart Rhythm Society; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons. 2011 ACCF/AHA guideline for the diagnosis and treatment of hypertrophic cardiomyopathy: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011 Dec 13;124(24):2761-96. doi: 10.1161/CIR.0b013e318223e230. Epub 2011 Nov 8. No abstract available.
PMID: 22068435RESULTGersh BJ, Maron BJ, Bonow RO, Dearani JA, Fifer MA, Link MS, Naidu SS, Nishimura RA, Ommen SR, Rakowski H, Seidman CE, Towbin JA, Udelson JE, Yancy CW; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; American Society of Echocardiography; American Society of Nuclear Cardiology; Heart Failure Society of America; Heart Rhythm Society; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons. 2011 ACCF/AHA guideline for the diagnosis and treatment of hypertrophic cardiomyopathy: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011 Dec 13;124(24):e783-831. doi: 10.1161/CIR.0b013e318223e2bd. Epub 2011 Nov 8. No abstract available.
PMID: 22068434RESULTAuthors/Task Force members; Elliott PM, Anastasakis A, Borger MA, Borggrefe M, Cecchi F, Charron P, Hagege AA, Lafont A, Limongelli G, Mahrholdt H, McKenna WJ, Mogensen J, Nihoyannopoulos P, Nistri S, Pieper PG, Pieske B, Rapezzi C, Rutten FH, Tillmanns C, Watkins H. 2014 ESC Guidelines on diagnosis and management of hypertrophic cardiomyopathy: the Task Force for the Diagnosis and Management of Hypertrophic Cardiomyopathy of the European Society of Cardiology (ESC). Eur Heart J. 2014 Oct 14;35(39):2733-79. doi: 10.1093/eurheartj/ehu284. Epub 2014 Aug 29. No abstract available.
PMID: 25173338RESULTDawson DK, Maceira AM, Raj VJ, Graham C, Pennell DJ, Kilner PJ. Regional thicknesses and thickening of compacted and trabeculated myocardial layers of the normal left ventricle studied by cardiovascular magnetic resonance. Circ Cardiovasc Imaging. 2011 Mar;4(2):139-46. doi: 10.1161/CIRCIMAGING.110.960229. Epub 2010 Dec 30.
PMID: 21193690RESULTLee PT, Dweck MR, Prasher S, Shah A, Humphries SE, Pennell DJ, Montgomery HE, Payne JR. Left ventricular wall thickness and the presence of asymmetric hypertrophy in healthy young army recruits: data from the LARGE heart study. Circ Cardiovasc Imaging. 2013 Mar 1;6(2):262-7. doi: 10.1161/CIRCIMAGING.112.979294. Epub 2013 Jan 10.
PMID: 23307776RESULTLu M, Zhao S, Jiang S, Yin G, Wang C, Zhang Y, Liu Q, Cheng H, Ma N, Zhao T, Chen X, Huang J, Zou Y, Song L, He Z, An J, Renate J, Xue H, Shah S. Fat deposition in dilated cardiomyopathy assessed by CMR. JACC Cardiovasc Imaging. 2013 Aug;6(8):889-98. doi: 10.1016/j.jcmg.2013.04.010. Epub 2013 Jul 10.
PMID: 23850250RESULTLu M, Zhao S, Yin G, Jiang S, Zhao T, Chen X, Tian L, Zhang Y, Wei Y, Liu Q, He Z, Xue H, An J, Shah S. T1 mapping for detection of left ventricular myocardial fibrosis in hypertrophic cardiomyopathy: a preliminary study. Eur J Radiol. 2013 May;82(5):e225-31. doi: 10.1016/j.ejrad.2012.12.014. Epub 2013 Jan 17.
PMID: 23333530RESULTFlorian A, Masci PG, De Buck S, Aquaro GD, Claus P, Todiere G, Van Cleemput J, Lombardi M, Bogaert J. Geometric assessment of asymmetric septal hypertrophic cardiomyopathy by CMR. JACC Cardiovasc Imaging. 2012 Jul;5(7):702-11. doi: 10.1016/j.jcmg.2012.03.011.
PMID: 22789938RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Minjie Lu, MD, PhD
Chinese Academy of Medical Sciences, Fuwai Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice Director of Magnetic Resonance Imaging
Study Record Dates
First Submitted
February 23, 2016
First Posted
February 26, 2016
Study Start
January 1, 2011
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
April 11, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will share