Chest PainPhase 2NCT00001961
MRI Evaluation of Chest Pain
A Phase 2 study testing MRI in people with Chest Pain and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
This study will assess the value of magnetic resonance imaging (MRI) in detecting heart attack and heart attack risk in patients who come to the hospital emergency room because of chest pain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chest Pain, Coronary Disease, Myocardial Infarction
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1999to Jan 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ages above age 21 (children are excluded because myocardial infarction is so rare in this population that the pre-test probability is comparable to the patients with less than 30 minutes of symptoms. Both of these groups have too small a fraction of true positive events to benefit from testing with a sensitivity and specificity of approximately 0.85. If initial results are better, we will reexamine the suitability of these tests for low risk populations).
- Capable of giving informed consent.
- 30 minutes of chest pain compatible with myocardial ischemia (chest pain score greater than 4).
- Less than 270 pounds.
Who cannot join
- Medical exclusions:
- Patient states she may be pregnant (confirmed by urine or blood testing).
- Severe congestive heart failure (unable to lie flat in bed).
- Subjects on a mechanical ventilator.
- MRI exclusions:
- Subjects with a cardiac pacemaker or implantable defibrillator.
Show all 11Show fewer
- Subjects with a cerebral aneurysm clip.
- Subjects with a neural stimulator (e.g. TENS-Unit).
- Subjects with any type of ear implant.
- Subjects with metal in eye (e.g. from machining).
- Subjects with implanted devices (e.g. insulin pump, drug infusion device).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, 20892
About this study
Official title: MRI Evaluation of Chest Pain Compatible With Myocardial Ischemia
This study will assess the value of magnetic resonance imaging (MRI) in detecting heart attack and heart attack risk in patients who come to the hospital emergency room because of chest pain. It will also investigate whether MRI can help predict the coronary status of patients 4 to 6 weeks and 1 year after emergency room admission.
Patients who come to the emergency room of Suburban Hospital in Bethesda, MD, because of chest pain may be asked to enroll in this study if they have not been diagnosed as having a heart attack. Participating patients will undergo a MRI scan as soon as emergency room doctors determine they are in stable condition. For this procedure, the patient lies on a table that slides into the MRI scanner-a large tubular machine with a magnetic field. During the scan, a contrast material is injected into the vein. This material brightens the image of the heart so that the blood flow can be seen. The scan will show if there are areas of heart muscle that received insufficient blood flow. A second scan will be done within 72 hours to look for coronary artery blockage that may require treatment. Patients will be followed by telephone 4 to 8 weeks after the scans and again 1 year after the scans to ask about any significant medical problems that may have occurred during those time periods.
This study will provide information that may improve emergency treatment of patients with acute chest pain by clarifying which patients require immediate medical treatment, which should be admitted to the hospital for further evaluation, and which may safely be discharged from the hospital.
Read the detailed description
Coronary artery disease remains the leading cause of death in the United States and results in high diagnostic and therapeutic costs. The overall costs associated with the care of patients with cardiovascular disease is projected to be $286.5 billion. Although MRI is a relatively expensive technology, this methodology can provide all the noninvasive diagnostic testing necessary to evaluate and triage patients with coronary artery disease. This "one stop shop" has the potential to lower overall testing on this important patient population and better delineate which patients require intervention. Beyond reproducing the results of existing diagnostic tests, MRI has unique abilities to characterize myocardial tissue adding information in the assessment of these patients that is not attainable by currently available methodologies. This study will examine the hypothesis that MRI assessment of regional LV function, resting myocardial perfusion, and myocardial tissue characteristics can accurately detect a higher fraction of patients with acute myocardial infarction than is possible with the ECG performed in the emergency department.
- Conditions
- Chest Pain, Coronary Disease, Myocardial Infarction
- Being tested
- MRI
- Keywords
- Myocardial Infarction, Coronary Artery Disease, Adenosine, Stress Testing, Perfusion
- Medical subject headings
- Chest Pain, Coronary Disease, Myocardial Infarction, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2000 (estimated)
- Study startDec 1999
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 360 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001961
- Sponsor's protocol ID
- 000025
- Other IDs
- 00-H-0025
- Status last verified
- Jan 2005
- First submitted
- 18 Jan 2000
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Selker HP. Coronary care unit triage decision aids: how do we know when they work? Am J Med. 1989 Nov;87(5):491-3. doi: 10.1016/s0002-9343(89)80602-3. No abstract available.
PubMed 2816964Weingarten SR, Ermann B, Riedinger MS, Shah PK, Ellrodt AG. Selecting the best triage rule for patients hospitalized with chest pain. Am J Med. 1989 Nov;87(5):494-500. doi: 10.1016/s0002-9343(89)80603-5.
PubMed 2816965Tatum JL, Jesse RL, Kontos MC, Nicholson CS, Schmidt KL, Roberts CS, Ornato JP. Comprehensive strategy for the evaluation and triage of the chest pain patient. Ann Emerg Med. 1997 Jan;29(1):116-25. doi: 10.1016/s0196-0644(97)70317-2.
PubMed 8998090
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Evaluation of Chest Pain Compatible With Myocardial Ischemia
- ClinicalTrials.gov ID
- NCT00001961
- Acronym / sponsor ID
- 000025
- Conditions
- Chest Pain, Coronary Disease, Myocardial Infarction
- Keywords
- Myocardial Infarction, Coronary Artery Disease, Adenosine, Stress Testing, Perfusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Dec 1999
- Study completion
- Jan 2005
- First posted
- 19 Jan 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the value of magnetic resonance imaging (MRI) in detecting heart attack and heart attack risk in patients who come to the hospital emergency room because of chest pain. It will also investigate whether MRI can help predict the coronary status of patients 4 to 6 weeks and 1 year after emergency room admission.
Patients who come to the emergency room of Suburban Hospital in Bethesda, MD, because of chest pain may be asked to enroll in this study if they have not been diagnosed as having a heart attack. Participating patients will undergo a MRI scan as soon as emergency room doctors determine they are in stable condition. For this procedure, the patient lies on a table that slides into the MRI scanner-a large tubular machine with a magnetic field. During the scan, a contrast material is injected into the vein. This material brightens the image of the heart so that the blood flow can be seen. The scan will show if there are areas of heart muscle that received insufficient blood flow. A second scan will be done within 72 hours to look for coronary artery blockage that may require treatment. Patients will be followed by telephone 4 to 8 weeks after the scans and again 1 year after the scans to ask about any significant medical problems that may have occurred during those time periods.
This study will provide information that may improve emergency treatment of patients with acute chest pain by clarifying which patients require immediate medical treatment, which should be admitted to the hospital for further evaluation, and which may safely be discharged from the hospital.
Detailed description
Coronary artery disease remains the leading cause of death in the United States and results in high diagnostic and therapeutic costs. The overall costs associated with the care of patients with cardiovascular disease is projected to be $286.5 billion. Although MRI is a relatively expensive technology, this methodology can provide all the noninvasive diagnostic testing necessary to evaluate and triage patients with coronary artery disease. This "one stop shop" has the potential to lower overall testing on this important patient population and better delineate which patients require intervention. Beyond reproducing the results of existing diagnostic tests, MRI has unique abilities to characterize myocardial tissue adding information in the assessment of these patients that is not attainable by currently available methodologies. This study will examine the hypothesis that MRI assessment of regional LV function, resting myocardial perfusion, and myocardial tissue characteristics can accurately detect a higher fraction of patients with acute myocardial infarction than is possible with the ECG performed in the emergency department.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Ages above age 21 (children are excluded because myocardial infarction is so rare in this population that the pre-test probability is comparable to the patients with less than 30 minutes of symptoms. Both of these groups have too small a fraction of true positive events to benefit from testing with a sensitivity and specificity of approximately 0.85. If initial results are better, we will reexamine the suitability of these tests for low risk populations).
- Capable of giving informed consent.
- 30 minutes of chest pain compatible with myocardial ischemia (chest pain score greater than 4).
- Less than 270 pounds.
Key exclusion criteria (11 listed)
- Patient states she may be pregnant (confirmed by urine or blood testing).
- Severe congestive heart failure (unable to lie flat in bed).
- Subjects on a mechanical ventilator.
- Subjects with a cardiac pacemaker or implantable defibrillator.
- Subjects with a cerebral aneurysm clip.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 2816964Selker HP. Coronary care unit triage decision aids: how do we know when they work? Am J Med. 1989 Nov;87(5):491-3. doi: 10.1016/s0002-9343(89)80602-3. No abstract available.
- Background: PubMed 2816965Weingarten SR, Ermann B, Riedinger MS, Shah PK, Ellrodt AG. Selecting the best triage rule for patients hospitalized with chest pain. Am J Med. 1989 Nov;87(5):494-500. doi: 10.1016/s0002-9343(89)80603-5.
- Background: PubMed 8998090Tatum JL, Jesse RL, Kontos MC, Nicholson CS, Schmidt KL, Roberts CS, Ornato JP. Comprehensive strategy for the evaluation and triage of the chest pain patient. Ann Emerg Med. 1997 Jan;29(1):116-25. doi: 10.1016/s0196-0644(97)70317-2.
Related trials for Chest Pain
Not yet recruiting
Effect of Warm Footbath Combined With Relaxation Exercise on Pain and Anxiety During Chest Tube Removal After Cardiac Surgery
Chest Tube Removal
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MRI in people with Chest Pain and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001961, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.