Myocardial IschemiaPhase 3NCT00001895
Electromechanical Mapping to Evaluate Heart Muscle
A Phase 3 study testing FDG and NH(3) in people with Myocardial Ischemia, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
Patients with narrowed heart arteries who undergo coronary angiography (imaging of the heart's blood vessels) may participate in this "heart mapping" study designed to gain information about the condition of different areas of the heart muscle. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- FDG and NH(3)
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1999to Dec 2001
- Phase
- Phase 3
- 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
Male or female patients greater than or equal to 21 years undergoing diagnostic cardiac catheterization.
Must not have unstable angina.
No significant unprotected left main disease (greater than 50% stenosis).
No recent myocardial infarction (less than 4 weeks).
Females must not be pregnant or lactating.
No chronic atrial fibrillation.
No prosthetic heart valves.
No significant aortic valve pathology (sclerosis or stenosis) which might prevent retrograde crossing of catheter across the aortic valve.
No left ventricular thrombus seen on echo.
No severe heart failure (NYHA Class 4).
No severe ectopy (greater than 1 every 10 beats) or ventricular tachycardia.
No active infections (fever and elevated white cell count).
Patients will not be considered for this protocol because of contraindications to MRI scan, as stated below:
Pacemaker
Implanted defibrillator
Cerebral aneurysm clips
Swan Ganz catheter with electrodes for a thermistor
Cochlear implants
Insulin pumps
Neural stimulator
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: Evaluation of Electromechanical Endocardial Mapping for Assessment of Myocardial Ischemia and Viability
Patients with narrowed heart arteries who undergo coronary angiography (imaging of the heart's blood vessels) may participate in this "heart mapping" study designed to gain information about the condition of different areas of the heart muscle.
In coronary angiography, a thin tube called a catheter is inserted through a small incision in the groin and pushed up to the heart. There, a contrast dye is injected, revealing areas of blockage in the coronary arteries-the vessels that supply blood to the heart muscle. As soon as the angiography is completed, patients in this study will undergo another procedure called "Biosense mapping." For this procedure, a special catheter with a tiny sensor at the tip will be inserted into the sheath that was used for the angiography and advanced to the heart's main pumping chamber-the left ventricle. The sensor detects the pattern of an electromagnetic field generated from a pad under the patient, and an image of the precise location of the catheter in 3-dimensional space can be seen on a computer screen. The catheter is then navigated to various precise locations in the ventricle, producing an electromechanical map that distinguishes scarred muscle tissue from healthy tissue-information that can be important in guiding treatment.
Read more
When this mapping is completed, the patient will be given a drug called dobutamine to increase the heartbeat, and the mapping will be repeated. The heart may also be mapped while the heart rate is increased with a pacing catheter to simulate exercise. The test will be stopped if adverse side effects develop.
Patients in the study will also have magnetic resonance imaging (MRI) and PET (positron emission tomography) scans to get additional information about the heart muscle, such as blood flow and metabolism rate.
Read the detailed description
A novel left ventricular (LV) mapping system (Biosense, Inc.) uses low-intensity magnetic field energy to determine the location of sensor-tipped catheter electrodes within the LV. On the basis of previous experimental and human studies correlating the extent of myocardial ischemia with the amplitude of electrical signals, we hypothesize that such an integrated LV electromechanical mapping system could be used to distinguish healthy from ischemic or immobile myocardium on the basis of the extent of electromechanical endocardial signals. If this hypothesis is confirmed, the ability to detect on-line myocardial viability and ischemia in the catheterization laboratory may be feasible.
The present study attempts to distinguish between ischemic, immobile, and normal myocardium by comparing LV electromechanical mapping data at rest and during pharmacologic stimulation, with imaging studies using MRI, PET, thallium and echo in patients with coronary artery disease.
- Conditions
- Myocardial Ischemia
- Being tested
- FDG, NH(3)
- Keywords
- Electromechanical Mapping, Myocardial Viability, Myocardial Ischemia, Positron Emission Tomography, Magnetic Resonance Imaging
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDGDrug
NH(3)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startAug 1999
- Study completionDec 2001
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 Myocardial IschemiaStudies 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 3
- Primary purpose
- Treatment
- Enrolment
- 71 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001895
- Sponsor's protocol ID
- 990153
- Other IDs
- 99-H-0153
- Status last verified
- Dec 2001
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Heyndrickx GR, Baig H, Nellens P, Leusen I, Fishbein MC, Vatner SF. Depression of regional blood flow and wall thickening after brief coronary occlusions. Am J Physiol. 1978 Jun;234(6):H653-9. doi: 10.1152/ajpheart.1978.234.6.H653.
PubMed 665778Perrone-Filardi P, Bacharach SL, Dilsizian V, Maurea S, Marin-Neto JA, Arrighi JA, Frank JA, Bonow RO. Metabolic evidence of viable myocardium in regions with reduced wall thickness and absent wall thickening in patients with chronic ischemic left ventricular dysfunction. J Am Coll Cardiol. 1992 Jul;20(1):161-8. doi: 10.1016/0735-1097(92)90153-e.
PubMed 1607518Dilsizian V, Rocco TP, Freedman NM, Leon MB, Bonow RO. Enhanced detection of ischemic but viable myocardium by the reinjection of thallium after stress-redistribution imaging. N Engl J Med. 1990 Jul 19;323(3):141-6. doi: 10.1056/NEJM199007193230301.
PubMed 2362606
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
- Evaluation of Electromechanical Endocardial Mapping for Assessment of Myocardial Ischemia and Viability
- ClinicalTrials.gov ID
- NCT00001895
- Acronym / sponsor ID
- 990153
- Conditions
- Myocardial Ischemia
- Keywords
- Electromechanical Mapping, Myocardial Viability, Myocardial Ischemia, Positron Emission Tomography, Magnetic Resonance Imaging
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Aug 1999
- Study completion
- Dec 2001
- First posted
- 4 Nov 1999 (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.
Patients with narrowed heart arteries who undergo coronary angiography (imaging of the heart's blood vessels) may participate in this "heart mapping" study designed to gain information about the condition of different areas of the heart muscle.
In coronary angiography, a thin tube called a catheter is inserted through a small incision in the groin and pushed up to the heart. There, a contrast dye is injected, revealing areas of blockage in the coronary arteries-the vessels that supply blood to the heart muscle. As soon as the angiography is completed, patients in this study will undergo another procedure called "Biosense mapping." For this procedure, a special catheter with a tiny sensor at the tip will be inserted into the sheath that was used for the angiography and advanced to the heart's main pumping chamber-the left ventricle. The sensor detects the pattern of an electromagnetic field generated from a pad under the patient, and an image of the precise location of the catheter in 3-dimensional space can be seen on a computer screen. The catheter is then navigated to various precise locations in the ventricle, producing an electromechanical map that distinguishes scarred muscle tissue from healthy tissue-information that can be important in guiding treatment.
When this mapping is completed, the patient will be given a drug called dobutamine to increase the heartbeat, and the mapping will be repeated. The heart may also be mapped while the heart rate is increased with a pacing catheter to simulate exercise. The test will be stopped if adverse side effects develop.
Patients in the study will also have magnetic resonance imaging (MRI) and PET (positron emission tomography) scans to get additional information about the heart muscle, such as blood flow and metabolism rate.
Detailed description
A novel left ventricular (LV) mapping system (Biosense, Inc.) uses low-intensity magnetic field energy to determine the location of sensor-tipped catheter electrodes within the LV. On the basis of previous experimental and human studies correlating the extent of myocardial ischemia with the amplitude of electrical signals, we hypothesize that such an integrated LV electromechanical mapping system could be used to distinguish healthy from ischemic or immobile myocardium on the basis of the extent of electromechanical endocardial signals. If this hypothesis is confirmed, the ability to detect on-line myocardial viability and ischemia in the catheterization laboratory may be feasible.
The present study attempts to distinguish between ischemic, immobile, and normal myocardium by comparing LV electromechanical mapping data at rest and during pharmacologic stimulation, with imaging studies using MRI, PET, thallium and echo in patients with coronary artery disease.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| FDG | Drug | – |
| NH(3) | Drug | – |
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 665778Heyndrickx GR, Baig H, Nellens P, Leusen I, Fishbein MC, Vatner SF. Depression of regional blood flow and wall thickening after brief coronary occlusions. Am J Physiol. 1978 Jun;234(6):H653-9. doi: 10.1152/ajpheart.1978.234.6.H653.
- Background: PubMed 1607518Perrone-Filardi P, Bacharach SL, Dilsizian V, Maurea S, Marin-Neto JA, Arrighi JA, Frank JA, Bonow RO. Metabolic evidence of viable myocardium in regions with reduced wall thickness and absent wall thickening in patients with chronic ischemic left ventricular dysfunction. J Am Coll Cardiol. 1992 Jul;20(1):161-8. doi: 10.1016/0735-1097(92)90153-e.
- Background: PubMed 2362606Dilsizian V, Rocco TP, Freedman NM, Leon MB, Bonow RO. Enhanced detection of ischemic but viable myocardium by the reinjection of thallium after stress-redistribution imaging. N Engl J Med. 1990 Jul 19;323(3):141-6. doi: 10.1056/NEJM199007193230301.
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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 3 study testing FDG and NH(3) in people with Myocardial Ischemia, 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.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 NCT00001895, 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; AzTrials last refreshed its copy on 30 Oct 2026.