NCT03874624

Brief Summary

Transversal retrospective and unicentric study. The investigators sought to determine the normal values for two-dimensional myocardial left atrial strain for the cardiology ultrasound system available in their centre (Philips EPIQ ultrasound machine and 10.8.5 QLAB cardiac analysis software). Studies performed in their department which meet the criteria for an adequate strain analysis will be retrospectively reviewed.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

March 14, 2019

Status Verified

March 1, 2019

Enrollment Period

3 months

First QC Date

March 1, 2019

Last Update Submit

March 12, 2019

Conditions

Atrial Function

Outcome Measures

Primary Outcomes (6)

  • Global peak reservoir strain.

    Percentage of peak reservoir strain for 4-, 2- and 3-chambers will be combined to report percentage of global peak reservoir strain.

    Through study completion, an average of 4 months.

  • Global pump strain.

    Percentage of pump reservoir strain for 4-, 2- and 3-chambers will be combined to report percentage of global pump strain.

    Through study completion, an average of 4 months.

  • Global conductance strain.

    Measured as the difference between global reservoir strain and gobal pump strain.

    Through study completion, an average of 4 months.

  • Global reservoir strain rate.

    Reservoir strain rate for 4-, 2- and 3-chambers will be combined to report global reservoir strain rate.

    Through study completion, an average of 4 months.

  • Global conductance strain rate.

    Conductance strain rate for 4-, 2- and 3-chambers will be combined to report global conductance strain rate.

    Through study completion, an average of 4 months.

  • Global pump strain rate.

    Pump strain rate for 4-, 2- and 3-chambers will be combined to report global pump strain rate.

    Through study completion, an average of 4 months.

Secondary Outcomes (10)

  • Age in years

    Through study completion, an average of 4 months.

  • Sex

    Through study completion, an average of 4 months.

  • Weight in kilograms

    Through study completion, an average of 4 months.

  • Height in meters

    Through study completion, an average of 4 months.

  • Left atrial volume

    Through study completion, an average of 4 months.

  • +5 more secondary outcomes

Interventions

two-dimensional speckle trackingDIAGNOSTIC_TEST

Analysis of myocardial left atrial strain using two-dimensional speckle tracking echocardiography.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy controls.

You may qualify if:

  • No history of cardiopathy / pneumopathy.
  • No history of hypertension or mellitus diabetes.

You may not qualify if:

  • Pregnancy.
  • Athletes.
  • Body mass index \< 16 or =\> 30 kg/m2.
  • Previous treatment with cardiotoxic chemotherapy.
  • Dilated left ventricle (telediastolic diameter index \> 30 mm/m2).
  • Interventricular septal thickness =\> 12 mm.
  • Dilated left atria (volume =\> 31 ml/m2).
  • Systolic pulmonary pressure =\> 35 mmHg.
  • Moderate or severe valvulopathy.
  • Incomplete or suboptimal left atrial visualization.
  • Frame rate \< 50 fps.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

RECRUITING

Central Study Contacts

Lidia Bos Real

CONTACT

0034935537058lbos@santpau.cat

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2019

First Posted

March 14, 2019

Study Start

February 22, 2019

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

March 14, 2019

Record last verified: 2019-03

Locations

ES(1)