Cardiovascular DiseasesNCT00006502
Myocardial Perfusion, Risk Factors, and Coronary Calcium
An observational study of Cardiovascular Diseases and Coronary Arteriosclerosis, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine whether an impairment of myocardial perfusion reserve is an early indicator of coronary artery disease. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Coronary Arteriosclerosis, Coronary Disease
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 2000to Jun 2005
- 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 Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To determine whether an impairment of myocardial perfusion reserve is an early indicator of coronary artery disease.
Read the detailed description
BACKGROUND:
Impairment of coronary vasofunction is believed to be one of the earliest manifestations of coronary heart disease (CHD). The impact of risk factors such as elevated cholesterol levels, diabetes, hypertension, and smoking on the coronary microcirculation remains largely unknown.
DESIGN NARRATIVE:
The cross-sectional study will determine whether an impairment of the myocardial perfusion reserve provides a marker of coronary heart disease (CHD) by comparing it to other novel measures of subclinical vascular disease, and by testing its association with risk factors for CHD. The study is ancillary to the Multi-Ethnic Study of Atherosclerosis ("MESA"), which is an NHLBI funded, prospective observational study of the characteristics of subclinical cardiovascular disease, i.e. disease detected non-invasively before it has produced signs and symptoms. In MESA new measures of subclinical disease such as coronary artery calcium and impaired brachial artery reactivity are to be examined to investigate their relationships to well-established risk factors and clinical events. Myocardial perfusion reserve (MPR)is a useful measure of coronary vasofunction that should be included in an evaluation of new measures of subclinical disease. An impaired MPR appears to be a specific early indicator of the functional impairment of the microcirculation in patients with risk factors for coronary artery disease. Magnetic resonance imaging (MRI) will be used as an advanced, quantitative imaging modality to determine in short (20 minute) exams the myocardial perfusion reserve in a group of 400 MESA participants. The study tests the hypothesis that impaired myocardial perfusion reserve indicates the presence of subclinical coronary atherosclerosis and coronary microvascular disease.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Medical subject headings
- Cardiovascular Diseases, Coronary Artery Disease, Coronary Disease, Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2000 (estimated)
- Study startSep 2000
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Michael Jerosch-Herold, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006502
- Sponsor's protocol ID
- 943
- Other IDs
- R01HL065580
- Status last verified
- Jul 2005
- First submitted
- 16 Nov 2000
- Last updated
- 29 Feb 2016
- Results posted
- No
Publications
Jerosch-Herold M, Swingen C, Seethamraju RT. Myocardial blood flow quantification with MRI by model-independent deconvolution. Med Phys. 2002 May;29(5):886-97. doi: 10.1118/1.1473135.
PubMed 12033585Swingen C, Seethamraju RT, Jerosch-Herold M. An approach to the three-dimensional display of left ventricular function and viability using MRI. Int J Cardiovasc Imaging. 2003 Aug;19(4):325-36. doi: 10.1023/a:1025450211508.
PubMed 14598902Jerosch-Herold M, Hu X, Murthy NS, Rickers C, Stillman AE. Magnetic resonance imaging of myocardial contrast enhancement with MS-325 and its relation to myocardial blood flow and the perfusion reserve. J Magn Reson Imaging. 2003 Nov;18(5):544-54. doi: 10.1002/jmri.10384.
PubMed 14579397Swingen CM, Seethamraju RT, Jerosch-Herold M. Feedback-assisted three-dimensional reconstruction of the left ventricle with MRI. J Magn Reson Imaging. 2003 May;17(5):528-37. doi: 10.1002/jmri.10290.
PubMed 12720262Jerosch-Herold M, Seethamraju RT, Swingen CM, Wilke NM, Stillman AE. Analysis of myocardial perfusion MRI. J Magn Reson Imaging. 2004 Jun;19(6):758-70. doi: 10.1002/jmri.20065.
PubMed 15170782
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Perfusion, Risk Factors, and Coronary Calcium
- ClinicalTrials.gov ID
- NCT00006502
- Acronym / sponsor ID
- 943
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 2000
- Study completion
- Jun 2005 (actual)
- First posted
- 17 Nov 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.
To determine whether an impairment of myocardial perfusion reserve is an early indicator of coronary artery disease.
Detailed description
BACKGROUND:
Impairment of coronary vasofunction is believed to be one of the earliest manifestations of coronary heart disease (CHD). The impact of risk factors such as elevated cholesterol levels, diabetes, hypertension, and smoking on the coronary microcirculation remains largely unknown.
DESIGN NARRATIVE:
The cross-sectional study will determine whether an impairment of the myocardial perfusion reserve provides a marker of coronary heart disease (CHD) by comparing it to other novel measures of subclinical vascular disease, and by testing its association with risk factors for CHD. The study is ancillary to the Multi-Ethnic Study of Atherosclerosis ("MESA"), which is an NHLBI funded, prospective observational study of the characteristics of subclinical cardiovascular disease, i.e. disease detected non-invasively before it has produced signs and symptoms. In MESA new measures of subclinical disease such as coronary artery calcium and impaired brachial artery reactivity are to be examined to investigate their relationships to well-established risk factors and clinical events. Myocardial perfusion reserve (MPR)is a useful measure of coronary vasofunction that should be included in an evaluation of new measures of subclinical disease. An impaired MPR appears to be a specific early indicator of the functional impairment of the microcirculation in patients with risk factors for coronary artery disease. Magnetic resonance imaging (MRI) will be used as an advanced, quantitative imaging modality to determine in short (20 minute) exams the myocardial perfusion reserve in a group of 400 MESA participants. The study tests the hypothesis that impaired myocardial perfusion reserve indicates the presence of subclinical coronary atherosclerosis and coronary microvascular disease.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- 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.
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 29 Feb 2016.
- Background: PubMed 12033585Jerosch-Herold M, Swingen C, Seethamraju RT. Myocardial blood flow quantification with MRI by model-independent deconvolution. Med Phys. 2002 May;29(5):886-97. doi: 10.1118/1.1473135.
- Background: PubMed 14598902Swingen C, Seethamraju RT, Jerosch-Herold M. An approach to the three-dimensional display of left ventricular function and viability using MRI. Int J Cardiovasc Imaging. 2003 Aug;19(4):325-36. doi: 10.1023/a:1025450211508.
- Background: PubMed 14579397Jerosch-Herold M, Hu X, Murthy NS, Rickers C, Stillman AE. Magnetic resonance imaging of myocardial contrast enhancement with MS-325 and its relation to myocardial blood flow and the perfusion reserve. J Magn Reson Imaging. 2003 Nov;18(5):544-54. doi: 10.1002/jmri.10384.
- Background: PubMed 12720262Swingen CM, Seethamraju RT, Jerosch-Herold M. Feedback-assisted three-dimensional reconstruction of the left ventricle with MRI. J Magn Reson Imaging. 2003 May;17(5):528-37. doi: 10.1002/jmri.10290.
- Background: PubMed 15170782Jerosch-Herold M, Seethamraju RT, Swingen CM, Wilke NM, Stillman AE. Analysis of myocardial perfusion MRI. J Magn Reson Imaging. 2004 Jun;19(6):758-70. doi: 10.1002/jmri.20065.
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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.
Michael Jerosch-Herold
University of Minnesota
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Coronary Arteriosclerosis, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006502, which also lists 5 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 29 Feb 2016.