Ignite Creation Date:
2024-05-06 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03217227
Status:
RECRUITING
Last Update Posted:
2023-04-12
First Post:
2017-07-11
Brief Title:
Evaluating Myocardial Ischemia in Chest Pain Using Exercise CMR
Sponsor:
National Heart Centre Singapore
Organization:
National Heart Centre Singapore
Study Overview
Official Title:
Evaluating Myocardial Ischemia in Chest Pain Using Cardiovascular Magnetic Resonance CMR Imaging Exercise Bike
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMPIRE
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
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
Detailed Description:
Suspected ischemic heart disease IHD or coronary artery disease CAD is commonly diagnosed by stress testing where patients undergo exercise tests in order to make their hearts work hard and beat fast to require more blood and oxygen Pharmacological-induced stress is employed in the case where the patient is unable to exercise Since plaque-narrowed arteries cannot supply enough oxygen-rich blood to meet the hearts needs the stress test can show signs and symptoms of IHD Some of the symptoms include abnormal changes in the heart rate or blood pressure shortness of breath chest pain or abnormal changes in the hearts rhythm and electrical activity
As part of the stress tests images of the heart are taken while the patient is exercising and while the patient is at rest The imaging stress tests will show how well the blood flows in and out of the heart An example would be a stress echocardiogram where an ultrasound is performed on the chest to produce video images of the heart to IHD is detected through development of new regional wall motion abnormalities or worsening of preexisting regional wall motions The patient will be required to exercise on a treadmill before lying on the examination bed for the ultrasound scan This however would require the patient to move from the treadmill to the bed which would result in some time delay
Another diagnostic test commonly used to diagnose IHD would be a nuclear scan known as myocardial perfusion imaging where a radioactive isotope acting as a tracer is injected into the bloodstream During exercise the tracer is monitored while it flows through the heart and lungs to allow detection for any blood-flow problems However this test would involve ionizing radiation due to the radioactive isotopic tracer used
A detailed test to view blood flow through the heart would be through a cardiac catheterization or an angiogram where a thin and flexible tube known as a catheter is threaded through an artery usually in the leg to the heart arteries An invisible dye is injected through the catheter and special x-rays will be taken while the dye flows through the coronary arteries allowing the doctor to study the blood flow through the heart and blood vessels Due to the nature of the catheterization with the insertion of the tube it makes the procedure invasive and hence involving risks although they are rare
Cardiovascular magnetic resonance CMR is able to accurately and non-radiatively assess the heart structure any scarring or lack of blood supply to the heart muscle A CMR-compatible cycle ergometer offers a one-stop diagnostic test that is non-radiative and non-invasive Hence our investigators aim to develop a protocol that does not require any invasive procedure by assessing its accuracy and develop reference ranges in healthy individuals
As part of the stress tests images of the heart are taken while the patient is exercising and while the patient is at rest The imaging stress tests will show how well the blood flows in and out of the heart An example would be a stress echocardiogram where an ultrasound is performed on the chest to produce video images of the heart to IHD is detected through development of new regional wall motion abnormalities or worsening of preexisting regional wall motions The patient will be required to exercise on a treadmill before lying on the examination bed for the ultrasound scan This however would require the patient to move from the treadmill to the bed which would result in some time delay
Another diagnostic test commonly used to diagnose IHD would be a nuclear scan known as myocardial perfusion imaging where a radioactive isotope acting as a tracer is injected into the bloodstream During exercise the tracer is monitored while it flows through the heart and lungs to allow detection for any blood-flow problems However this test would involve ionizing radiation due to the radioactive isotopic tracer used
A detailed test to view blood flow through the heart would be through a cardiac catheterization or an angiogram where a thin and flexible tube known as a catheter is threaded through an artery usually in the leg to the heart arteries An invisible dye is injected through the catheter and special x-rays will be taken while the dye flows through the coronary arteries allowing the doctor to study the blood flow through the heart and blood vessels Due to the nature of the catheterization with the insertion of the tube it makes the procedure invasive and hence involving risks although they are rare
Cardiovascular magnetic resonance CMR is able to accurately and non-radiatively assess the heart structure any scarring or lack of blood supply to the heart muscle A CMR-compatible cycle ergometer offers a one-stop diagnostic test that is non-radiative and non-invasive Hence our investigators aim to develop a protocol that does not require any invasive procedure by assessing its accuracy and develop reference ranges in healthy individuals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None