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

April 9, 2017 updated by: Minjie Lu, Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Recruiting
        • Fuwai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
apical hypertrophic cardiomyopathy
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Collaborators

Peking Union Medical College Hospital
Xuanwu Hospital, Beijing
Beijing Chao Yang Hospital
Beijing Anzhen Hospital

Investigators

  • Principal Investigator: Minjie Lu, MD, PhD, Fuwai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

February 23, 2016

First Submitted That Met QC Criteria

February 25, 2016

First Posted (Estimate)

February 26, 2016

Study Record Updates

Last Update Posted (Actual)

April 11, 2017

Last Update Submitted That Met QC Criteria

April 9, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHCM001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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