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Status unknownNCT02692508Updated Apr 11, 2017

Prognosis of Subjects With Unexplainable Precordial Deep T-wave Inversion Without Wall Thickness> 15mm

An observational study in Cardiomyopathy and Hypertrophic, sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Status unknown at 1 site in China. Open to participants aged 16 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-11.

Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
16 Years to 60 Years
Sex
All
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Study 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.

Read the detailed description

Apical hypertrophic cardiomyopathy (AHCM) is a special form of non obstructive hypertrophic cardiomyopathy (HCM), in which the hypertrophy of myocardium predominantly involves the apex of the left ventricle (LV). Generally, patients with AHCM show obvious negative T waves on precordial leads on electrocardiogram (ECG). However, clinically some patients present dramatic T-wave inversion with the apical thickness less than the diagnostic criteria of AHCM. In order to get a moderate diagnosis, these participants may undergo lengthy investigation with implications for lifestyle modifications and increase the health care expenses. The investigators wonder they may share their fate with patients who have overt AHCM. Further study of these patients is needed for a proper diagnosis and treatment.

In conventional diagnostic criteria published by American heart association (AHA)/American college of cardiology foundation (ACCF) in 2011, or European society of cardiology (ESC) in 2014, the LV wall thickness≥15 mm is the unified diagnostic criteria of HCM. These guidelines, however, did not give additional regulations or instructions for the diagnosis of AHCM. It is suspected that these criteria may be too strict for AHCM, as the normal left ventricular wall thins towards the apex and the normal values are lower naturally in the apical versus the basal segments.

Comparing with echocardiography, the superior spatial and temporal resolution of CMR makes it more sensitive to diagnose AHCM at earlier stage, much earlier than the appearance of "ace-of-spades" configuration. In a previous study, only 60% of patients with apical segmental hypertrophy that were confirmed by CMR were diagnosed by echocardiography. Echocardiography has its technical limitations for assessing apex due to the limited regional spatial resolution. Additionally, CMR can offer prognostic features, such as apical scar and apical aneurysms.

The investigators thus sought to evaluate the morphorage 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.

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Conditions studied

  • Cardiomyopathy
  • Hypertrophic

Keywords

  • cardiovascular MRI
  • apical hypertrophic cardiomyopathy
  • giant negative T-wave
  • wall thickness
  • Nuclear Magnetic Resonance
  • Early Diagnosis
  • Prognosis
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In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's planned enrollment of 100 is below the median of 153 across 515 observational studies indexed under Cardiomyopathies.

Browse Cardiomyopathies studies →

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital is the lead sponsor of 141 studies on the registry; 48 are open to participants now.

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

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Who can participate

Ages eligible
16 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

subjects with unexplainable precordial deep T-wave inversion on ECG and with apical thickness less than 15mm

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. All cause mortality

    Time frame: one year

Secondary outcomes

  1. apical hypertrophic cardiomyopathy

    Time frame: one year

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Study locations

1 of 1 sites recruiting
  • Fuwai Hospital
    Beijing, Beijing 100037, China
    Recruiting
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References and documents

Publications

  • 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. PubMed 22068435 ↗
  • 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: 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. PubMed 22068434 ↗
  • Authors/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. PubMed 25173338 ↗
  • Dawson 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. PubMed 21193690 ↗
  • Lee 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. PubMed 23307776 ↗
  • Lu 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. PubMed 23850250 ↗
  • Lu 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. PubMed 23333530 ↗
  • Florian 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. Erratum In: JACC Cardiovasc Imaging. 2012 Sep;5(9):968. PubMed 22789938 ↗

Individual participant data

Plan to share: Yes

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02692508
Lead sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborators
Beijing Chao Yang Hospital, Beijing Anzhen Hospital, Peking Union Medical College Hospital, Xuanwu Hospital, Beijing
Responsible party
Minjie Lu (Vice Director of Magnetic Resonance Imaging, Chinese Academy of Medical Sciences, Fuwai Hospital) — Principal investigator
First posted
Feb 26, 2016
Start date
Jan 2011
Primary completion
Dec 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Apr 11, 2017

Study contacts

Xiuyu Chen, PhD
Contact
fwchenxiuyu@163.com
+86 10 88398175
Minjie Lu, MD, PhD
principal investigator · Chinese Academy of Medical Sciences, Fuwai Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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