Relationship of Different Electrocardiographic Parameters... | NCT03542526

Studies
Relationship of Different Electrocardiographic Parameters and Ambulatory Blood Pressure Parameters to Detect Left Ventricular Hypertrophy

NCT03542526

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

May 31, 2018Actual

Enrollment

73Estimated

Phase

Not provided

Conditions

Hypertension

Interventions

electrogradiogram
ambulatory blood prussre

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Estimated

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Mar 27, 2018

First Submission Date that Met QC Criteria

May 20, 2018

First Posted Date

May 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2018

Last Update Posted Date

May 31, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michael Sadeq, cardiology resident, principle investigator, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To review the accuracy of electrocardiography in screening for left ventricular hypertrophy in patients with hypertension.

Detailed Description

Arterial hypertension is a major cause of coronary heart disease, stroke, and heart failure. Several studies have shown that left ventricular hypertrophy is an important risk factor in patients with hypertension, leading to a fivefold to 10-fold increase in cardiovascular risk,1 2 3 4 5 which is similar to the increase seen in patients with a history of myocardial infarction.6 The presence of left ventricular hypertrophy, in addition to hypertension, thus has important implications for assessing risk and managing patients, including decisions on interventions other than antihypertensive treatment, such as lipid lowering treatment and lifestyle modifications.7 8 Accurate and early diagnosis of left ventricular hypertrophy is therefore an important component of the care of patients with hypertension.

Decisions about treatment should be based on assessments of hypertensive target organ damage and overall cardiovascular risk. The appropriate diagnostic work-up of suspected left ventricular hypertrophy in patients with hypertension is less clear, however. There is many electrocardiographic indexes for the diagnosis of left ventricular hypertrophy, based on the standard 12 lead electrocardiogram, have been described. Many of the proposed indexes have remained anecdotal, but others are commonly used, including the Sokolow-Lyon index,9 the Cornell voltage index,10 the Cornell product index,11 the Gubner index,12 and the Romhilt-Estes scores.13 However, debate about their comparative diagnostic value continues.14 15 We did a systematic review to clarify the accuracy of different electrocardiographic indexes, with emphasis on their ability to rule out left ventricular hypertrophy in patients with arterial hypertension.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

73Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
electrogradiogram	Device	12 lead ecg ambulatory blood prussre		blood measuring device
ambulatory blood prussre	Device	ambulatory blood pressure to measure blood pressure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
minimize complicate of hypertension	screening with hypertensive patient	1 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients ranging from 20t o 80 years attending the hypertension outpatient clinic for ambulatory blood pressure measurement will be consecutively enrolled

Exclusion Criteria:

Patients with ischemic heart disease.
Patients with advanced respiratory, renal, or hepatic disease
Patients with uninterpretable ECG or ABPM recordings

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All eligible patients attending the Hypertension outpatient clinic over two year duration starting from November 2018, will be consecutively enrolled

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yehia t Keshk, professor	Contact	20882335120		yehia@aun.edu.eg
Tarek a nagib, lecturer	Contact	201099975128		Tarkaf76@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AssiutU	Recruiting	Asyut			Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20362725	Background	Jain A, Tandri H, Dalal D, Chahal H, Soliman EZ, Prineas RJ, Folsom AR, Lima JA, Bluemke DA. Diagnostic and prognostic utility of electrocardiography for left ventricular hypertrophy defined by magnetic resonance imaging in relationship to ethnicity: the Multi-Ethnic Study of Atherosclerosis (MESA). Am Heart J. 2010 Apr;159(4):652-8. doi: 10.1016/j.ahj.2009.12.035.
17726091

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases