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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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24 April 2023 |
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Main ID: |
NCT03217227 |
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Date of registration:
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11/07/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluating Myocardial Ischemia in Chest Pain Using Exercise CMR
EMPIRE |
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Scientific title:
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Evaluating Myocardial Ischemia in Chest Pain Using Cardiovascular Magnetic Resonance (CMR) Imaging Exercise Bike |
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Date of first enrolment:
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May 1, 2017 |
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Target sample size:
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300 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03217227 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Singapore
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Contacts
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Name:
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Le Thu Thao, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Heart Research Institute Singapore |
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Name:
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Thu Thao Le, PhD |
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Address:
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Telephone:
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67042241 |
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Email:
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le.thu.thao@nhcs.com.sg |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Healthy Volunteers:
- 21 years and above
- Normal physical examination
- No known significant medical history
- Able to give informed consent
Patients:
- 21 years and above
- Stable angina or angina-equivalent
- Has at least one of the following risk factors:
1. Smoking
2. Diabetes (fasting glucose level > 140 mg/dL)
3. Hyperlipidemia (total cholesterol level > 250 mg/dL)
4. Abnormal ECG
5. Hypertension
Exclusion Criteria:
Healthy Volunteers:
- Contraindications to CMR implantable devices, cerebral aneurysm clips, cochlear
implants
- Claustrophobia
- Women who are pregnant
- Inability to comply with study protocol
- Not able to exercise
Patients:
- Unstable cardiac conditions that are deemed by primary investigator to be unsuitable
for this study
- Prior coronary revascularization or percutaneous coronary intervention
- Pulmonary disease
- Anemia
- Asthma
- Hyperthermia
- Hyperthyroidism
- Sympathomimetic toxicity
- Polycythemia
- Severely uncontrolled hypertension despite being on at least 3 anti-hypertensive
medications
Age minimum:
21 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Coronary Artery Disease
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Myocardial Ischemia
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Coronary Heart Disease
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Cardiovascular Diseases
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Ischemic Heart Disease
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Microvascular Coronary Artery Disease
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Intervention(s)
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Other: Cardiovascular Magnetic Resonance Imaging with Exercise Bike
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Other: Retinal Photography (Optional)
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Diagnostic Test: I123 MIBG Scintigraphy (Optional)
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Procedure: Cardiac Catheterization
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Primary Outcome(s)
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First occurrence of cardiovascular event
[Time Frame: One year]
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Secondary ID(s)
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2017/2123
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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