NCT04959357

Brief Summary

The study was designed to evaluate the left ventricular longitudinal strain and strain rate assessed by 2D-STI in patients with coronary microvascular dysfunction (CMD) or obstructive coronary artery disease (CAD) , to investigate the effect of different types of ischemic heart disease on the LV systolic function, and to explore the value of LS on the diagnosis of coronary microvascular dysfunction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
242

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 15, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 13, 2021

Completed
Last Updated

July 13, 2021

Status Verified

July 1, 2021

Enrollment Period

8 months

First QC Date

June 27, 2021

Last Update Submit

July 12, 2021

Conditions

Keywords

two-dimensional speckle tracking imagingstraincoronary microvascular dysfunction

Outcome Measures

Primary Outcomes (1)

  • global longitudinal strain

    global longitudinal strain of CMD group and obstructive CAD group

    15/3/2018-30/12/2018

Study Arms (3)

coronary microvascular dysfunction group

Diagnostic Test: Two dimensional speckle tracking imaging

obstructive coronary artery disease

Diagnostic Test: Two dimensional speckle tracking imaging

control group

Diagnostic Test: Two dimensional speckle tracking imaging

Interventions

lobal longitudinal strain and strain rate, subendocardial LS and subepicardial LS were quantified by two dimensional speckle tracking imaging

control groupcoronary microvascular dysfunction groupobstructive coronary artery disease

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 242 patients were enrolled, including 102 males (42.1%) and 140 females (57.9%). Their ages ranged from 44 to 81 years, with an average age of (62.6 + 8.3) years.

You may qualify if:

  • age from 18-85 years

You may not qualify if:

  • patients with history of myocardial infarction or abnormal wall motion suggested by conventional echocardiography
  • patients with acute heart failure, chronic heart failure or LVEF values less than 50%
  • patients with congenital heart disease, severe valvular disease, severe bradycardia, high atrioventricular block and atrial fibrillation
  • patients who did not store ultrasound images or whose ultrasound images were unclear
  • patients who had incomplete clinical data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Peking University Third Hospital, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Sprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Li Zhaoping, professor

    Peking University Third Hospital

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

June 27, 2021

First Posted

July 13, 2021

Study Start

March 15, 2018

Primary Completion

October 30, 2018

Study Completion

December 30, 2018

Last Updated

July 13, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations