Diagnostic Study of Transthoracic Echocardiography for Coronary Heart Disease

Sponsor

Xiang Xie (Other)

Overall Status

Completed

CT.gov ID

NCT05164601

Collaborator

(none)

300

Enrollment

Locations

16.9

Actual Duration (Months)

150

Patients Per Site

8.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a prospective, single-center clinical trial，Comparison of transthoracic echocardiography and coronary angiography in coronary heart disease using a paired-analysis clinical trial.This study is based on the basis of clinical screening for coronary heart disease.

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease	Diagnostic Test: Echocardiography test

Detailed Description

Patients who were hospitalized in our department of cardiology during the period of 2011.08-2019.01 will be consecutively enrolled.Thorough cardiac ultrasound and coronary angiography were performed to assess coronary stenosis after admission.To evaluate the sensitivity, specificity, misdiagnosis rate, and missed diagnosis rate of coronary heart disease by echocardiography as the "gold standard" for diagnosis of coronary angiography.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

300 participants

Observational Model:

Case-Crossover

Time Perspective:

Prospective

Official Title:

Diagnostic Study of Transthoracic Echocardiography for Coronary Heart Disease

Actual Study Start Date :

Feb 1, 2020

Actual Primary Completion Date :

Jun 30, 2021

Actual Study Completion Date :

Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Observation group	Diagnostic Test: Echocardiography test Contrast echocardiography and coronary angiography

Arm

Intervention/Treatment

Observation group

Diagnostic Test: Echocardiography test

Contrast echocardiography and coronary angiography

Outcome Measures

Primary Outcome Measures

sensitivity, specificity, misdiagnosis rate and missed diagnosis [10 days]
The sensitivity, specificity, misdiagnosis rate and missed diagnosis rate of echocardiography in diagnosis of coronary heart disease

Secondary Outcome Measures

Factors related to missed diagnosis and misdiagnosis in the diagnosis [10 days]
Factors related to missed diagnosis and misdiagnosis in the diagnosis of CAD
Characteristics of coronary blood flow [10days]
Characteristics of coronary blood flow under echocardiography in patients with coronary heart disease

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

First admitted to hospital for chest pain and considered for diagnosis of coronary heart disease.
Patients with relatively stable disease who can withstand elective coronary angiography.
Cardiac ultrasound assessment before coronary angiography during hospitalization.

Exclusion Criteria:

No coronary angiography record.
No cardiac ultrasound record.
Cardiac ultrasonography is completed after coronary angiography.
Severe heart valve disease.
Severe congenital heart disease.
Hyperdynamic heart disease such as hyperthyroidism and anemia.
Pulmonary heart disease.
Hypertrophic obstructive cardiomyopathy.
According to the guidelines for coronary heart disease diagnosis, patients do not need coronary angiography.
Malignant tumor.
Acute coronary syndrome.
Pericardial disease.
Previously diagnosed as coronary heart disease or PCI.
Mental or legal incapacity.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang	China	630000
2	The First Affiliated Hospital of Xinjiang Medicial University	Ürümqi	Xinjiang	China	830000