Coronary Artery Disease Clinical Trial
Official title:
Multi-center Trial of SPECT Myocardial Blood Flow Quantitation for Detection of Coronary Artery Disease
Verified date | January 2021 |
Source | China National Center for Cardiovascular Diseases |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Patients with suspected or known coronary artery disease who are scheduled for clinically indicated SPECT myocardial perfusion imaging (MPI) and will receive invasive coronary angiogram are recruited to receive SPECT MBF study.
Status | Completed |
Enrollment | 221 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 79 Years |
Eligibility | Inclusion Criteria: - Age 18 ~ 79 years old - Any CAD risk factor - CAD related symptoms - Intermediate to high probability of CAD - Suspected or known CAD on a stable medication regime - Able and willing to comply with the study procedures - Written informed consent Exclusion Criteria: - History or risk of severe bradycardia - History of myocardial infarction, dilated cardiomyopathy, hypertrophic cardiomyopathy, valve issue or congenital heart disease - Wheezing asthma or COPD - Known second- or third-degree AV block - Known hypersensitivity to dipyridamole or adenosine - Breastfeeding or pregnancy - Claustrophobia or inability to lie still in a supine position - Unwillingness or inability to provide informed consent |
Country | Name | City | State |
---|---|---|---|
China | China-Japanese Friendship Hospital | Beijing | |
China | Fuwai Hospital | Beijing | |
China | Teda International Cardiovascular Hospital | Tanjin | |
China | Central China Fuwai Hospital | Zhengzhou |
Lead Sponsor | Collaborator |
---|---|
China National Center for Cardiovascular Diseases |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The diagnostic accuracy of MBF and MPI | The diagnostic accuracy of MBF and MPI while angiography is utilized as the reference standard | Through the study completion up to 12 months |
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