Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT03217227 |
Other study ID # |
2017/2123 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
May 1, 2017 |
Est. completion date |
March 1, 2025 |
Study information
Verified date |
April 2023 |
Source |
National Heart Centre Singapore |
Contact |
Thu Thao Le, PhD |
Phone |
67042241 |
Email |
le.thu.thao[@]nhcs.com.sg |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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 heart's 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 heart's 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.