The Value of Wearable Electrocardiogram in the Diagnosis of Coronary Artery Disease

NCT05515666 | Unknown

• 1 other identifier: 2020-ZX68
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

ECG is one of the classic tests for coronary artery disease, but patients with coronary artery disease often have no onset of typical symptoms at the time of consultation, so it is difficult to capture ischemic changes on a conventional ECG. In this study, a diagnostic test was performed to assess the diagnostic value of wearable ECG for coronary artery disease, with the gold standard of coronary angiography and quantitative flow fraction. In addition, we followed up with the enrolled participants for 1 year to assess the relationship between wearable ECG and long-term prognosis.

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; Electrocardiogram

Outcome Measures

Primary Outcomes (1)

• The Diagnostic Yield of wearable electrocardiogram for the diagnosis of obstructive CAD in whole population and in the subgroups including patients of different genders and age groups

  The results of wearable electrocardiogram (for example, ST segment change) will be compared with coronary angiography, The diagnostic standard of coronary angiography for obstructive CAD is anatomic coronary narrowing \>= 90% or Quantitative Flow Ratio \<=80%.

  an average of 2 year

Interventions

Wearable electrocardiogram DIAGNOSTIC_TEST

All participants will have their ECG monitored at home using a wearable ECG, and then be hospitalized for coronary angiography and quantitative flow fraction to confirm the presence of coronary artery disease.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with suspected coronary artery disease and cannot get a diagnosis by routine examination such as traditional ECG.

You may qualify if:

• age \>=18 years \& age \<=75 years;
• with suspected coronary artery disease;
• with any clinical indication for percutaneous coronary intervention;
• left ventricular ejection fraction \>40%.

You may not qualify if:

• acute myocardial infarction;
• rheumatic heart disease, malignant arrhythmia;
• valvular heart disease;
• thoracic deformities, infections, skin ulcers, allergies, etc. who cannot use wearable ECG;
• severe hepatic impairment;
• renal failure;
• iodine allergy;
• known pregnancy；
• inability to provide informed consent；
• currently participating in another trial before reaching primary endpoint.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Hongjian Wang

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Hongjian Wang, Doctor

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: August 25, 2022
• Study Start: April 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)