IschemiaNCT00661323
Evaluating a New Echocardiography Imaging Procedure for Evaluating Heart Function
An observational study of Ischemia and Myocardial Infarction, run by Yale University at 1 site in United States.
Trial summary
Magnetic resonance imaging (MRI) and echocardiography are two imaging methods that are used to obtain pictures of the heart and assess heart function. This study will evaluate a new, four-dimensional echocardiography approach of obtaining heart images to determine if it is as effective at evaluating heart function as… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ischemia, Myocardial Infarction, Ischemic Heart Disease
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 2013
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will consist of two groups: 1. Normal volunteers will be recruited through the use of an approved study recruitment flyer. 2. Chemotherapy patients will be approached at the time of their nuclear scan to rule out cardiac disease prior to chemotherapy. These patients will be referred to the study by their doctor for the assessment of heart function.
Who may be able to join
- No evidence of underlying cardiac disease based on history or electrocardiogram (ECG)
- Adequate intravenous access in one arm
Who cannot join
- Pregnant or breastfeeding; if pre-menopausal, not practicing acceptable method of birth control
- History of any other medical condition that is likely to hinder study conduct or pose a safety concern, in the opinion of the investigator
- History of cardiac disease, including heart attack or heart valve disease
- Uncontrolled high blood pressure, defined as systolic blood pressure higher than 160 mm Hg and/or diastolic pressure higher than 100 mm Hg
- Abnormal ECG or chest pain syndrome
- Claustrophobia
- Resting heart rate greater than 110 bpm
- Unable to undergo MRI procedure (e.g., pacemaker, metallic implants)
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University/Magnetic Resonance Research Center (MR-TAC)/Yale New Haven Hospital
New Haven, Connecticut, 06520
About this study
Official title: Left Ventricular Strain Quantification From 4D Echocardiography
Magnetic resonance imaging (MRI) and echocardiography are two imaging methods that are used to obtain pictures of the heart and assess heart function. This study will evaluate a new, four-dimensional echocardiography approach of obtaining heart images to determine if it is as effective at evaluating heart function as MRI.
Read the detailed description
MRI is a non-invasive method of obtaining images of the body. An MRI is conducted by having a person lie down on a narrow table, which then slides into a large tunnel-like tube. Powerful magnets and radio waves scan the body and a computer records the resulting signals. An echocardiography is a non-invasive ultrasound test that uses sound waves to create images of the heart. It is performed by having a doctor move a wand-like device over a patient's chest. The device then converts sound waves into pictures of the heart. Currently, a special MRI technique is used to evaluate heart function; however, MRI is expensive and cannot be used on critically ill patients. Echocardiography can be performed at a patient's bedside and it may be a more effective way of assessing heart function. The purpose of this study is to determine the effectiveness of a new four-dimensional echocardiography approach at evaluating heart function. Results from this study may be used to diagnose and treat patients more effectively in the future.
This study will enroll healthy people who do not have heart disease and people who are receiving chemotherapy who do not have heart disease. Participants will have a physical examination and a medical records review. MRI scans and a four-dimensional echocardiography of the heart will be performed. There will be no additional study visits.
- Conditions
- Ischemia, Myocardial Infarction, Ischemic Heart Disease
- Medical subject headings
- Ischemia, Myocardial Infarction, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Healthy volunteers will be recruited through the use of an approved study recruitment flyer. | |
| 2 | Chemotherapy patients will be approached at the time of their nuclear scan to rule out cardiac disease prior to chemotherapy. These patients will be referred to the study by their doctor for the assessment of heart function. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish baseline strain patterns for future studies evaluating alterations in left ventricular strain/strain rates associated with regional myocardial ischemia and injury
Measured: Measured at participants' study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startJul 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for IschemiaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Albert J. Sinusas, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661323
- Sponsor's protocol ID
- 0608001734_B
- Other IDs
- R01HL082640
- Status last verified
- Jun 2016
- First submitted
- 16 Apr 2008
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Constable RT, Rath KM, Sinusas AJ, Gore JC. Development and evaluation of tracking algorithms for cardiac wall motion analysis using phase velocity MR imaging. Magn Reson Med. 1994 Jul;32(1):33-42. doi: 10.1002/mrm.1910320106.
PubMed 8084235Duncan J, Shi P, Constable T, Sinusas A. Physical and geometrical modeling for image-based recovery of left ventricular deformation. Prog Biophys Mol Biol. 1998;69(2-3):333-51. doi: 10.1016/s0079-6107(98)00014-5.
PubMed 9785945Shi P, Sinusas AJ, Constable RT, Ritman E, Duncan JS. Point-tracked quantitative analysis of left ventricular surface motion from 3-D image sequences. IEEE Trans Med Imaging. 2000 Jan;19(1):36-50. doi: 10.1109/42.832958.
PubMed 10782617Papademetris X, Sinusas AJ, Dione DP, Duncan JS. Estimation of 3D left ventricular deformation from echocardiography. Med Image Anal. 2001 Mar;5(1):17-28. doi: 10.1016/s1361-8415(00)00022-0.
PubMed 11231174Sinusas AJ, Papademetris X, Constable RT, Dione DP, Slade MD, Shi P, Duncan JS. Quantification of 3-D regional myocardial deformation: shape-based analysis of magnetic resonance images. Am J Physiol Heart Circ Physiol. 2001 Aug;281(2):H698-714. doi: 10.1152/ajpheart.2001.281.2.H698.
PubMed 11454574Meyer FG, Constable RT, Sinusas AJ, Duncan JS. Tracking myocardial deformation using phase contrast MR velocity fields: a stochastic approach. IEEE Trans Med Imaging. 1996;15(4):453-65. doi: 10.1109/42.511749.
PubMed 18215927Shi P, Sinusas AJ, Constable RT, Duncan JS. Volumetric deformation analysis using mechanics-based data fusion: Applications in cardiac motion recovery. International J Computer Vision 35:87-107, 1999
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Ventricular Strain Quantification From 4D Echocardiography
- ClinicalTrials.gov ID
- NCT00661323
- Acronym / sponsor ID
- 0608001734_B
- Conditions
- Ischemia, Myocardial Infarction, Ischemic Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 18 Apr 2008 (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.
Magnetic resonance imaging (MRI) and echocardiography are two imaging methods that are used to obtain pictures of the heart and assess heart function. This study will evaluate a new, four-dimensional echocardiography approach of obtaining heart images to determine if it is as effective at evaluating heart function as MRI.
Detailed description
MRI is a non-invasive method of obtaining images of the body. An MRI is conducted by having a person lie down on a narrow table, which then slides into a large tunnel-like tube. Powerful magnets and radio waves scan the body and a computer records the resulting signals. An echocardiography is a non-invasive ultrasound test that uses sound waves to create images of the heart. It is performed by having a doctor move a wand-like device over a patient's chest. The device then converts sound waves into pictures of the heart. Currently, a special MRI technique is used to evaluate heart function; however, MRI is expensive and cannot be used on critically ill patients. Echocardiography can be performed at a patient's bedside and it may be a more effective way of assessing heart function. The purpose of this study is to determine the effectiveness of a new four-dimensional echocardiography approach at evaluating heart function. Results from this study may be used to diagnose and treat patients more effectively in the future.
This study will enroll healthy people who do not have heart disease and people who are receiving chemotherapy who do not have heart disease. Participants will have a physical examination and a medical records review. MRI scans and a four-dimensional echocardiography of the heart will be performed. There will be no additional study visits.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Healthy volunteers will be recruited through the use of an approved study recruitment flyer. |
| 2 | – | –Chemotherapy patients will be approached at the time of their nuclear scan to rule out cardiac disease prior to chemotherapy. These patients will be referred to the study by their doctor for the assessment of heart function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will consist of two groups: 1. Normal volunteers will be recruited through the use of an approved study recruitment flyer. 2. Chemotherapy patients will be approached at the time of their nuclear scan to rule out cardiac disease prior to chemotherapy. These patients will be referred to the study by their doctor for the assessment of heart function.
Key inclusion criteria (2 listed)
- No evidence of underlying cardiac disease based on history or electrocardiogram (ECG)
- Adequate intravenous access in one arm
Key exclusion criteria (8 listed)
- Pregnant or breastfeeding; if pre-menopausal, not practicing acceptable method of birth control
- History of any other medical condition that is likely to hinder study conduct or pose a safety concern, in the opinion of the investigator
- History of cardiac disease, including heart attack or heart valve disease
- Uncontrolled high blood pressure, defined as systolic blood pressure higher than 160 mm Hg and/or diastolic pressure higher than 100 mm Hg
- Abnormal ECG or chest pain syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Establish baseline strain patterns for future studies evaluating alterations in left ventricular strain/strain rates associated with regional myocardial ischemia and injury
Time frame: Measured at participants' study visit
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 30 Mar 2020.
- Background: PubMed 8084235Constable RT, Rath KM, Sinusas AJ, Gore JC. Development and evaluation of tracking algorithms for cardiac wall motion analysis using phase velocity MR imaging. Magn Reson Med. 1994 Jul;32(1):33-42. doi: 10.1002/mrm.1910320106.
- Background: PubMed 9785945Duncan J, Shi P, Constable T, Sinusas A. Physical and geometrical modeling for image-based recovery of left ventricular deformation. Prog Biophys Mol Biol. 1998;69(2-3):333-51. doi: 10.1016/s0079-6107(98)00014-5.
- Background: PubMed 10782617Shi P, Sinusas AJ, Constable RT, Ritman E, Duncan JS. Point-tracked quantitative analysis of left ventricular surface motion from 3-D image sequences. IEEE Trans Med Imaging. 2000 Jan;19(1):36-50. doi: 10.1109/42.832958.
- Background: PubMed 11231174Papademetris X, Sinusas AJ, Dione DP, Duncan JS. Estimation of 3D left ventricular deformation from echocardiography. Med Image Anal. 2001 Mar;5(1):17-28. doi: 10.1016/s1361-8415(00)00022-0.
- Background: PubMed 11454574Sinusas AJ, Papademetris X, Constable RT, Dione DP, Slade MD, Shi P, Duncan JS. Quantification of 3-D regional myocardial deformation: shape-based analysis of magnetic resonance images. Am J Physiol Heart Circ Physiol. 2001 Aug;281(2):H698-714. doi: 10.1152/ajpheart.2001.281.2.H698.
- Background: PubMed 18215927Meyer FG, Constable RT, Sinusas AJ, Duncan JS. Tracking myocardial deformation using phase contrast MR velocity fields: a stochastic approach. IEEE Trans Med Imaging. 1996;15(4):453-65. doi: 10.1109/42.511749.
- BackgroundShi P, Sinusas AJ, Constable RT, Duncan JS. Volumetric deformation analysis using mechanics-based data fusion: Applications in cardiac motion recovery. International J Computer Vision 35:87-107, 1999
Related trials for Ischemia
Recruiting
Efficacy and Safety of Ischemic Preconditioning Therapy Versus Optimal Medical Therapy in Reducing the Recurrence of Ischemic Events in Symptomatic Moyamoya Disease
Moya Moya Disease, Moyamoya Syndrome
RecruitingPhase 1/2
Safety and Efficacy of CG-BM1 in Ischemic Stroke
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
Not yet recruitingPhase 3
Recombinant Human Prourokinase for Acute Ischemic Stroke in the Extended Window Selected by CT-Based Artificial Intelligence
Acute Ischemic Stroke
Recruiting
Effects of Mirror Therapy and Motor Imagery on Upper Limb Motor Functions in Middle Cerebral Artery Stroke
Stroke
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
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.
Albert J. Sinusas, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemia and Myocardial Infarction, run by Yale University 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 2 inclusion and 8 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 30 Mar 2020. 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.
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.
What does the primary outcome measure?
Establish baseline strain patterns for future studies evaluating alterations in left ventricular strain/strain rates associated with regional myocardial ischemia and injury (time frame: Measured at participants' study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00661323, which also lists 7 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 30 Mar 2020.