Evaluating Myocardial Ischemia in Chest Pain Using Exercise CMR
EMPIRE
1 other identifier
observational
300
1 country
2
Brief Summary
Ischemic Heart Disease (IHD) is a condition of recurring chest pain or discomfort that occurs when a part of the heart is not receiving sufficient blood flow. It is a major public health concern internationally and in Singapore, the leading cause of death from cardiovascular disease. Cardiovascular magnetic resonance (CMR) has the ability to assess heart structures, scarring or lack of blood supply to the heart muscle with great accuracy and without any radiation involved. A CMR-compatible cycle ergometer can offer a safe and low cost stress equipment to assess heart function and motion abnormalities, and restrictions of the blood supply to the heart tissues due to partial or complete blockages of the blood vessels. This study aims
- 1.to develop an exercise-CMR stress protocol by testing its feasibility and robustness in assessing changes in cardiac volumes and function due to physical exertion in healthy individuals and
- 2.to assess the accuracy of the multiparametric stress-CMR as a diagnostic tool for ischemic-causing coronary artery disease (CAD) with coronary fractional flow reserve (FFR) as a reference.
- 3.to measure the overall economic impact of ischaemic heart disease by estimating the direct and indirect medical costs for each participant. The current sample costs will be extrapolated to estimate the annual costs of treating and managing ischaemic heart disease in the local population.
- 4.to evaluate the effects of coronary microvascular dysfunction on coronary flow and regulation, physiological response and cardiac sympathetic signaling in patients with chest pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2017
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 11, 2017
CompletedFirst Posted
Study publicly available on registry
July 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedApril 12, 2023
April 1, 2023
7.8 years
July 11, 2017
April 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
First occurrence of cardiovascular event
The outcomes are obtained via hospital records or phone follow-ups
One year
Study Arms (2)
Healthy Volunteer
Healthy Volunteers will undergo the following study procedures: 1. Cardiovascular Magnetic Resonance Imaging with Exercise Bike 2. Blood Sampling 3. Activity and Lifestyle Questionnaires 4. Fat Mass Measurement
Patients with Stable Angina
Patients will undergo the following study procedures: 1. Cardiovascular Magnetic Resonance Imaging with Exercise Bike 2. Blood Sampling 3. Cardiac Catheterization 4. Activity, Lifestyle and Medication Compliance Questionnaires 5. Fat Mass Measurement 6. Retinal Photography (Optional) 7. I123 MIBG scan (Optional)
Interventions
A rest scan is performed and a gadolinium contrast may be administered during the scan (depending on the kidney function). After the rest scan is completed, images of the subject's heart during exercise via cycling in the supine position, will be scanned.
It is a procedure to diagnose and treat cardiovascular diseases by inserting a long and thin tube known as a catheter into the artery or vein in the neck, groin or arm and threaded through the blood vessels to the heart. A coronary angiogram is also performed during the procedure where an invisible contrast dye (only visible in the X-rays) is injected through the catheter and X-ray images scanned will show the flow of the dye through the heart arteries to determine any blockages in the arteries. In the case where there is severe narrowings, fractional flow reserve (FFR) may be performed to measure the pressure in the coronary arteries. If there is no significant narrowing lesions, the interventionist may perform additional flow resistance measurements of the small vessels to further investigate the cause of angina
The test studies the structure and function of the eye vessels. It involves using eye drops to dilate the pupils, allowing the retinal photographer to have a better view of the back of the eye.
The test studies the cardiac sympathetic signalling that may help to identify patients with high risks of adverse events. The scan consists of 2 acquisitions of images 3-4 hours apart. For this study, only patients without clinically significant lesions (diagnosed via the cardiac catetherisation and have normal FFR results) will undergo this test.
Eligibility Criteria
The major source of recruitment for healthy volunteers will be from an existing database of healthy volunteers who have participated in the biobank program and have indicated interest in future studies. Other sources include co-workers of the department who volunteer and indicate on the Informed Consent Document that their participation was entirely voluntary and not coerced. Study Team members are ineligible. The major source of recruitment for patients with stable angina will be from the imaging and admission databases of the National Heart Centre Singapore. Patients are also referred by their attending healthcare professionals. The primary physicians of the patients identified will be notified and recruitment will only proceed if the primary physician is agreeable.
You may qualify if:
- Healthy Volunteers:
- years and above
- Normal physical examination
- No known significant medical history
- Able to give informed consent
- Patients:
- years and above
- Stable angina or angina-equivalent
- Has at least one of the following risk factors:
- Smoking
- Diabetes (fasting glucose level \> 140 mg/dL)
- Hyperlipidemia (total cholesterol level \> 250 mg/dL)
- Abnormal ECG
- Hypertension
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
National Heart Centre Singapore
Singapore, 169609, Singapore
National Heart Centre Singapore
Singapore, Singapore
Related Publications (1)
Le TT, Ang BWY, Bryant JA, Chin CY, Yeo KK, Wong PEH, Ho KW, Tan JWC, Lee PT, Chin CWL, Cook SA. Multiparametric exercise stress cardiovascular magnetic resonance in the diagnosis of coronary artery disease: the EMPIRE trial. J Cardiovasc Magn Reson. 2021 Mar 4;23(1):17. doi: 10.1186/s12968-021-00705-8.
PMID: 33658056DERIVED
Biospecimen
Approximately 30mL of blood in total will be drawn, where 25mL (equivalent to 5 teaspoons) of blood will be drawn before the exercise stress test and 5mL (equivalent to 1 teaspoon) of blood will be drawn after the exercise stress test. Blood samples will be collected from all participants.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Le Thu Thao, PhD
National Heart Research Institute Singapore
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2017
First Posted
July 14, 2017
Study Start
May 1, 2017
Primary Completion
March 1, 2025
Study Completion
March 1, 2025
Last Updated
April 12, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share