CardiomyopathyNCT02692508
Prognosis of Subjects With Unexplainable Precordial Deep T-wave Inversion Without Wall Thickness> 15mm
An observational study of Cardiomyopathy and Hypertrophic, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiomyopathy, Hypertrophic
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: subjects with unexplainable precordial deep T-wave inversion on ECG and with apical thickness less than 15mm
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital
Beijing, Beijing Municipality, 100037
Xiuyu Chen, PhD, +86 10 88398175, fwchenxiuyu@163.com
About this study
Official title: Morphological and Functional Changes and Prognosis of Subjects With Unexplainable Precordial Deep T-wave Inversion Without Apical Wall Thickness> 15mm
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.
- Conditions
- Cardiomyopathy, Hypertrophic
- Keywords
- cardiovascular MRI, apical hypertrophic cardiomyopathy, giant negative T-wave, wall thickness, Nuclear Magnetic Resonance, Early Diagnosis, Prognosis
- Medical subject headings
- Cardiomyopathies, Hypertrophy, Apical Hypertrophic Cardiomyopathy, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: one year
Secondary outcomes (1)
apical hypertrophic cardiomyopathy
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startJan 2011
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Beijing Anzhen Hospital, Peking Union Medical College Hospital, Xuanwu Hospital, Beijing
- Responsible party
- Principal investigator, Minjie Lu, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Minjie Lu, MD, PhD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692508
- Sponsor's protocol ID
- AHCM001
- Status last verified
- Apr 2017
- First submitted
- 23 Feb 2016
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
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 22068435Gersh 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 22068434Authors/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 25173338Dawson 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 21193690Lee 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 23307776Lu 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 23850250Lu 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 23333530Florian 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.
PubMed 22789938
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological and Functional Changes and Prognosis of Subjects With Unexplainable Precordial Deep T-wave Inversion Without Apical Wall Thickness> 15mm
- ClinicalTrials.gov ID
- NCT02692508
- Acronym / sponsor ID
- AHCM001
- Conditions
- Cardiomyopathy, Hypertrophic
- Keywords
- cardiovascular MRI, apical hypertrophic cardiomyopathy, giant negative T-wave, wall thickness, Nuclear Magnetic Resonance, Early Diagnosis, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Beijing Anzhen Hospital, Peking Union Medical College Hospital, Xuanwu Hospital, Beijing
- Study start
- Jan 2011
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 26 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- subjects with unexplainable precordial deep T-wave inversion on ECG and with apical thickness less than 15mm
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All cause mortality
Time frame: one year
1 secondary outcome
apical hypertrophic cardiomyopathy
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Results publication: PubMed 22068435Gersh 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.
- Results publication: PubMed 22068434Gersh 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.
- Results publication: PubMed 25173338Authors/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.
- Results publication: PubMed 21193690Dawson 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.
- Results publication: PubMed 23307776Lee 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.
- Results publication: PubMed 23850250Lu 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.
- Results publication: PubMed 23333530Lu 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.
- Results publication: PubMed 22789938Florian 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minjie Lu, MD, PhD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathy and Hypertrophic, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiuyu Chen, PhD (+86 10 88398175, fwchenxiuyu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02692508, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.