Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 26 of 181 for:    Recruiting, Not yet recruiting, Available Studies | Chest pain

Evaluating Myocardial Ischemia in Chest Pain Using Exercise CMR (EMPIRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03217227
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : July 14, 2017
Sponsor:
Information provided by (Responsible Party):
National Heart Centre Singapore

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.

Condition or disease Intervention/treatment
Ischemic Heart Disease Coronary Artery Disease Cardiovascular Diseases Myocardial Ischemia Coronary Heart Disease Other: Cardiovascular Magnetic Resonance Imaging with Exercise Bike Procedure: Cardiac Catherization Other: Retinal Photography (Optional)

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 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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluating Myocardial Ischaemia in Chest Pain Using Cardiovascular Magnetic Resonance (CMR) Imaging Exercise Bike
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Other: Cardiovascular Magnetic Resonance Imaging with Exercise Bike
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.
Other Names:
  • Bike MRI
  • CMR stress protocol

Patients with Chest Pain

Patients will undergo the following study procedures:

  1. Cardiovascular Magnetic Resonance Imaging with Exercise Bike
  2. Blood Sampling
  3. Cardiac Catherization
  4. Activity, Lifestyle and Medication Compliance Questionnaires
  5. Retinal Photography (Optional)
Other: Cardiovascular Magnetic Resonance Imaging with Exercise Bike
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.
Other Names:
  • Bike MRI
  • CMR stress protocol

Procedure: Cardiac Catherization

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.

Other Names:
  • Cath/PCI
  • Coronary Angiogram

Other: Retinal Photography (Optional)
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.




Primary Outcome Measures :
  1. First occurrence of cardiovascular event [ Time Frame: One year ]
    This outcomes are obtained via hospital records or by a phone follow-up


Biospecimen Retention:   Samples With DNA

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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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 chest pain 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.

Criteria

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
  • Has at least one of the following risk factors:

    1. Smoking
    2. Diabetes (fasting glucose level > 140 mg/dL)
    3. Hyperlipidemia (total cholestrol 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
  • Pulmonary disease
  • Anemia
  • Hyperthermia
  • Hyperthyroidism
  • Sympathomimetic toxicity
  • Polycythemia
  • Severely uncontrolled hypertension despite being on at least 3 anti-hypertensive medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03217227


Locations
Layout table for location information
Singapore
National Heart Centre Singapore Recruiting
Singapore, Singapore, 169609
Contact: Terrance Chua, MBBS    6704 2298    terrance.chua.s.j@singhealth.com.sg   
Contact: Briana Ang, BSc    6704 2298    briana.ang.w.y@nhcs.com.sg   
Principal Investigator: Calvin Chin, MBBS, PhD         
Sub-Investigator: Le Thu Thao, PhD         
Sponsors and Collaborators
National Heart Centre Singapore

Publications:
Fihn SD, Gardin JM, Abrams J, Berra K, Blankenship JC, Dallas AP, Douglas PS, Foody JM, Gerber TC, Hinderliter AL, King SB 3rd, Kligfield PD, Krumholz HM, Kwong RY, Lim MJ, Linderbaum JA, Mack MJ, Munger MA, Prager RL, Sabik JF, Shaw LJ, Sikkema JD, Smith CR Jr, Smith SC Jr, Spertus JA, Williams SV; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American College of Physicians; American Association for Thoracic Surgery; Preventive Cardiovascular Nurses Association; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons. 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2012 Dec 18;60(24):e44-e164. doi: 10.1016/j.jacc.2012.07.013. Epub 2012 Nov 19.

Layout table for additonal information
Responsible Party: National Heart Centre Singapore
ClinicalTrials.gov Identifier: NCT03217227     History of Changes
Other Study ID Numbers: 2017/2123
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Chest Pain
Pain
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Ischemia
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms