CardiomyopathyNCT00027170

Technical Development of Cardiovascular Magnetic Resonance Imaging

An observational study of Cardiomyopathy and Congenital Heart Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study will explore new ways of using magnetic resonance imaging (MRI) to evaluate the heart and blood vessels of patients with cardiovascular disease, including better detection of myocardial infarction (heart attack) and blockage of heart and leg arteries. Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Cardiomyopathy, Congenital Heart Disease, Cardiovascular Disease
What is being tested?: Siemens MRI scanner
Type of treatment: Injection or infusion, Medical device
How many people: 8,781 participants
Where: 2 sitesUnited States
Study dates: 26 Nov 2001to 19 Nov 2020
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 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with cardiovascular diseases and healthy subjects 18 years of age or older were recruited within this protocol. The exclusion criteria were developed from standard clinical practice but were more restrictive to err on the side of safety. Recruitment was via referral from local physicians. In addition, advertisements were placed in the "Washington Post". Finally, the protocol was listed on the NIH websites. A patient could participate in any combination of these tests/procedures. Clinical judgment was used to determine the number of tests/procedures suitable for a given patient. Specifically, the responsible physician avoided prolonging tests/procedures in patients in accordance with the patient's clinical status.

Who may be able to join

None listed.

Who cannot join

Exclusion Criteria for All Arms of the Protocol:
Patients with a contraindication to MRI scanning will be excluded. These contraindications include patients with the following devices:
Central nervous system aneurysm clips;
Implanted neural stimulator;
Implanted cardiac pacemaker or defibrillator;
Cochlear implant;

Show all 27Show fewer

Ocular foreign body (e.g. metal shavings);
Implanted Insulin pump;
Metal shrapnel or bullet.
In addition, the following patient groups will be excluded:
Pregnant women (Patients who are uncertain as to whether they are pregnant will be required to have a screening urine or blood pregnancy test)
Patients with active symptoms of myocardial ischemia occurring despite maximally tolerated doses of oral antianginal therapy and intravenous nitroglycerin
Furthermore, the following patient groups will be excluded from studies involving the administration of MRI contrast agents:
lactating women unless they are willing to discard breast milk for 24 hours after receiving gadolinium
renal disease (estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73 m(2) body surface area)
The eGFR will be used to estimate renal function if reported by the laboratory, or as reported by NIH Clinical Center or Suburban Hospital or other clinically certified laboratories. Otherwise, estimated glomerular filtration rate (eGFR) can be based on the Modification of Diet in Renal Disease (MDRD) study equation (see below) in subjects with stable renal function. This formula is not applicable to patients with acute renal insufficiency:
eGFR (ml/min/1.73 m(2)) equal to 175 times (serum creatinine)-1.154 times (age)-0.203 times 0.742 (if the subject is female) times1.212 (if the subject is black)
Additional Exclusion Criteria for Dobutamine, or Vasodilator Stress MRI:
Myocardial infarction within 48 hours
Uncontrolled congestive heart failure
Severe hypertension (SBP greater than 200, DBP greater than 110) (exclusion only for dobutamine and bicycle)
Atrial fibrillation. This exclusion only applies to Dobutamine stress.
Frequent PVC s (more than 1 every 10 heart beats or non-sustained ventricular tachycardia (greater than 4 beat runs) or ongoing sustained ventricular tachycardia. This exclusion only applies to Dobutamine and Bicycle stress
Patients with narrow angle glaucoma and known or suspected prostatic obstruction will not receive atropine
Additional Exclusion Criteria for PET/MR perfusion scans
Pregnant patients
Patients that are breast feeding

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Suburban Hospital
Bethesda, Maryland, 20814
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892

Other trials in United States

About this study

Patients 18 years of age and older with cardiovascular disease may be eligible for this study.

All participants will have magnetic resonance imaging of the heart. MRI uses a magnetic field and radio waves to show structural and chemical changes in tissues. For the procedure, the patient lies on a table surrounded by a metal cylinder (the scanner). A 'gadolinium contrast' material may be injected into the patient s vein during part of the study to brighten the images. Patients wear earplugs during the scan to muffle loud knocking sounds caused by the electrical switching of the magnetic fields. They will be asked to hold their breath intermittently for 5 to 20 seconds during the scan. They will be monitored with an electrocardiogram (EKG) during the procedure and will be in contact by intercom at all times with the person performing the scan. Patients can request to stop the study and come out of the scanner at any time. The procedure may last from 30 to 90 minutes. An echocardiogram a test that uses sound waves to produce pictures of the heart and blood vessels-may be done to confirm the MRI findings. In addition, patients may undergo one or more of the following optional studies:

Dobutamine stress MRI - This test uses dobutamine-a medicine that simulates exercise by increasing heart rate and heart function-to detect blockages in the coronary arteries (vessels that supply oxygen and nutrients to the heart) and locate areas of the heart that are permanently damaged, perhaps by a previous heart attack. For this test, MRI pictures of the heart are taken before, during and after administration of dobutamine. Gadolinium may be injected during part of the study to brighten the images. An EKG will be used to monitor the heart during the procedure.
Vasodilator MRI - The procedure and objectives of this test are the same as those described for dobutamine stress MRI, except that this study uses dipyridamole or adenosine. These drugs dilate blood vessels, causing increased blood flow to the heart.
Plethysmography MRI - This test determines the presence and severity of narrowing in arteries that supply blood to the leg. Blockage of these vessels often causes pain while walking. This study will compare plethysmography MRI with venous occlusion plethysmography, an older method of measuring blood flow in the legs. For venous occlusion plethysmography, a large blood pressure cuff is placed around the upper leg and a strain gauge (thin elastic band) is placed around the calf. The pressure cuff is inflated very tightly for 5 minutes to block blood flow to the leg, and another pressure cuff over the ankle is also inflated. When the large cuff is deflated, blood rushes to the leg, a smaller cuff is inflated to a low pressure, and the strain gauge measures the maximum blood flow to the leg for 1 or 2 more minutes. This procedure is done once or twice outside the MRI scanner and once or twice inside the scanner. The scans are performed as described above for the dobutamine and vasodilator studies. The strain gauge is not used for plethysmography MRI the MRI pictures are used to measure flow.

Read the detailed description

The purpose of this protocol is to allow development and testing of new MRI techniques suitable for evaluating patients with cardiovascular disease. Since such technical development work often depends on preliminary studies in healthy volunteers, the protocol also recruits healthy subjects. This protocol will provide the framework for technical development scans in patients with cardiovascular disease.

Conditions: Cardiomyopathy, Congenital Heart Disease, Cardiovascular Disease, Cardiac Magnetic Resonance Imaging, Acute Myocardial Infarction
Being tested: Siemens MRI scanner
Keywords: Myocardial Infarction, Myocardial Viability, Myocardial Perfusion, Myocardial Ischemia, Atherosclerosis
Medical subject headings: Cardiomyopathies, Heart Defects, Congenital, Cardiovascular Diseases, Myocardial Infarction, Myocardial Ischemia, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Siemens MRI scannerDevice
Investigational or research MRI coils may be used in the protocol. The coils are noninvasive devices external to the body. The coils act as antennae to receive small radiofrequency signals out of the body. Coils of the type we use are used daily in clinical MRI practice.

Study groups in NCT00027170
Study group	Role	What they receive
Participants with cardiovascular diseases		Patients may receive an intravenous injection of gadobutrol (Gadavist) not to exceed 0.2 mmol/kg of Gd per bolus injection and per examination. Receives: Device: Siemens MRI scanner
Healthy Participants		Patients may receive an intravenous injection of gadobutrol (Gadavist) not to exceed 0.2 mmol/kg of Gd per bolus injection and per examination. Receives: Device: Siemens MRI scanner

What is being measured

The primary outcome is the main question the study is designed to answer.

examine the rate of major cardiovascular events (MACE) defined as cardiac death, non- fatal myocardial infarction, cerebrovascular / transient ischemic attack, and revascularization in patients undergoing stress or rest cardiac MRI
examine the rate of major cardiovascular events (MACE) defined as cardiac death, non- fatal myocardial infarction, cerebrovascular / transient ischemic attack, and revascularization in patients undergoing stress or rest cardiac MRI and to relate these events to the extent of ischemia and infarction seen on the MRI exams
Measured: Ongoing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Nov 200119 Nov 2020

First posted28 Nov 2001 (estimated)
Study start26 Nov 2001
Primary completion5 Apr 2018
Study completion19 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for CardiomyopathyStudies 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
Observational model: Cohort
Time perspective: Prospective
Enrolment: 8,781 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00027170
Sponsor's protocol ID: 020050
Other IDs: 02-H-0050
Status last verified: 22 Dec 2020
First submitted: 27 Nov 2001
Last updated: 30 Mar 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Baer FM, Voth E, Theissen P, Schicha H, Sechtem U. Gradient-echo magnetic resonance imaging during incremental dobutamine infusion for the localization of coronary artery stenoses. Eur Heart J. 1994 Feb;15(2):218-25. doi: 10.1093/oxfordjournals.eurheartj.a060479.
PubMed 8005123
Baer FM, Voth E, Schneider CA, Theissen P, Schicha H, Sechtem U. Comparison of low-dose dobutamine-gradient-echo magnetic resonance imaging and positron emission tomography with [18F]fluorodeoxyglucose in patients with chronic coronary artery disease. A functional and morphological approach to the detection of residual myocardial viability. Circulation. 1995 Feb 15;91(4):1006-15. doi: 10.1161/01.cir.91.4.1006.
PubMed 7850935
Baer FM, Voth E, Theissen P, Schneider CA, Schicha H, Sechtem U. Coronary artery disease: findings with GRE MR imaging and Tc-99m-methoxyisobutyl-isonitrile SPECT during simultaneous dobutamine stress. Radiology. 1994 Oct;193(1):203-9. doi: 10.1148/radiology.193.1.8090892.
PubMed 8090892
Fujikura K, Sathya B, Acharya T, Benovoy M, Jacobs M, Sachdev V, Hsu LY, Arai AE. CMR provides comparable measurements of diastolic function as echocardiography. Sci Rep. 2024 May 22;14(1):11658. doi: 10.1038/s41598-024-61992-6.
PubMed 38778036
Ta AD, Hsu LY, Conn HM, Winkler S, Greve AM, Shanbhag SM, Chen MY, Patricia Bandettini W, Arai AE. Fully quantitative pixel-wise analysis of cardiovascular magnetic resonance perfusion improves discrimination of dark rim artifact from perfusion defects associated with epicardial coronary stenosis. J Cardiovasc Magn Reson. 2018 Mar 8;20(1):16. doi: 10.1186/s12968-018-0436-0.
PubMed 29514708
Hsu LY, Jacobs M, Benovoy M, Ta AD, Conn HM, Winkler S, Greve AM, Chen MY, Shanbhag SM, Bandettini WP, Arai AE. Diagnostic Performance of Fully Automated Pixel-Wise Quantitative Myocardial Perfusion Imaging by Cardiovascular Magnetic Resonance. JACC Cardiovasc Imaging. 2018 May;11(5):697-707. doi: 10.1016/j.jcmg.2018.01.005. Epub 2018 Feb 14.
PubMed 29454767
Nielles-Vallespin S, Kellman P, Hsu LY, Arai AE. FLASH proton density imaging for improved surface coil intensity correction in quantitative and semi-quantitative SSFP perfusion cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2015 Feb 17;17(1):16. doi: 10.1186/s12968-015-0120-6.
PubMed 25827180
Chen MY, Bandettini WP, Shanbhag SM, Vasu S, Booker OJ, Leung SW, Wilson JR, Kellman P, Hsu LY, Lederman RJ, Arai AE. Concordance and diagnostic accuracy of vasodilator stress cardiac MRI and 320-detector row coronary CTA. Int J Cardiovasc Imaging. 2014 Jan;30(1):109-19. doi: 10.1007/s10554-013-0300-0. Epub 2013 Oct 12.
PubMed 24122452

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Technical Development of Cardiovascular Magnetic Resonance Imaging
ClinicalTrials.gov ID: NCT00027170
Acronym / sponsor ID: 020050
Conditions: Cardiomyopathy, Congenital Heart Disease, Cardiovascular Disease, Cardiac Magnetic Resonance Imaging, Acute Myocardial Infarction
Keywords: Myocardial Infarction, Myocardial Viability, Myocardial Perfusion, Myocardial Ischemia, Atherosclerosis
Study type: Observational
Recruitment status: Completed
Enrolment: 8,781 participants (actual)
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
Study start: 26 Nov 2001 (actual)
Primary completion: 5 Apr 2018 (actual)
Study completion: 19 Nov 2020 (actual)
First posted: 28 Nov 2001 (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 18 years of age and older with cardiovascular disease may be eligible for this study.

Dobutamine stress MRI - This test uses dobutamine-a medicine that simulates exercise by increasing heart rate and heart function-to detect blockages in the coronary arteries (vessels that supply oxygen and nutrients to the heart) and locate areas of the heart that are permanently damaged, perhaps by a previous heart attack. For this test, MRI pictures of the heart are taken before, during and after administration of dobutamine. Gadolinium may be injected during part of the study to brighten the images. An EKG will be used to monitor the heart during the procedure.
Vasodilator MRI - The procedure and objectives of this test are the same as those described for dobutamine stress MRI, except that this study uses dipyridamole or adenosine. These drugs dilate blood vessels, causing increased blood flow to the heart.
Plethysmography MRI - This test determines the presence and severity of narrowing in arteries that supply blood to the leg. Blockage of these vessels often causes pain while walking. This study will compare plethysmography MRI with venous occlusion plethysmography, an older method of measuring blood flow in the legs. For venous occlusion plethysmography, a large blood pressure cuff is placed around the upper leg and a strain gauge (thin elastic band) is placed around the calf. The pressure cuff is inflated very tightly for 5 minutes to block blood flow to the leg, and another pressure cuff over the ankle is also inflated. When the large cuff is deflated, blood rushes to the leg, a smaller cuff is inflated to a low pressure, and the strain gauge measures the maximum blood flow to the leg for 1 or 2 more minutes. This procedure is done once or twice outside the MRI scanner and once or twice inside the scanner. The scans are performed as described above for the dobutamine and vasodilator studies. The strain gauge is not used for plethysmography MRI the MRI pictures are used to measure flow.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Participants with cardiovascular diseases	–	Device: Siemens MRI scannerPatients may receive an intravenous injection of gadobutrol (Gadavist) not to exceed 0.2 mmol/kg of Gd per bolus injection and per examination.
Healthy Participants	–	Device: Siemens MRI scannerPatients may receive an intravenous injection of gadobutrol (Gadavist) not to exceed 0.2 mmol/kg of Gd per bolus injection and per examination.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with cardiovascular diseases and healthy subjects 18 years of age or older were recruited within this protocol. The exclusion criteria were developed from standard clinical practice but were more restrictive to err on the side of safety. Recruitment was via referral from local physicians. In addition, advertisements were placed in the "Washington Post". Finally, the protocol was listed on the NIH websites. A patient could participate in any combination of these tests/procedures. Clinical judgment was used to determine the number of tests/procedures suitable for a given patient. Specifically, the responsible physician avoided prolonging tests/procedures in patients in accordance with the patient's clinical status.

Key inclusion criteria (0 listed)

Key exclusion criteria (27 listed)

Exclusion Criteria for All Arms of the Protocol:
In addition, the following patient groups will be excluded:
Furthermore, the following patient groups will be excluded from studies involving the administration of MRI contrast agents:
The eGFR will be used to estimate renal function if reported by the laboratory, or as reported by NIH Clinical Center or Suburban Hospital or other clinically certified laboratories. Otherwise, estimated glomerular filtration rate (eGFR) can be based on the Modification of Diet in Renal Disease (MDRD) study equation (see below) in subjects with stable renal function. This formula is not applicable to patients with acute renal insufficiency:
eGFR (ml/min/1.73 m(2)) equal to 175 times (serum creatinine)-1.154 times (age)-0.203 times 0.742 (if the subject is female) times1.212 (if the subject is black)

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
Siemens MRI scannerInvestigational or research MRI coils may be used in the protocol. The coils are noninvasive devices external to the body. The coils act as antennae to receive small radiofrequency signals out of the body. Coils of the type we use are used daily in clinical MRI practice.	Device	Healthy Participants, Participants with cardiovascular diseases

Primary outcome

examine the rate of major cardiovascular events (MACE) defined as cardiac death, non- fatal myocardial infarction, cerebrovascular / transient ischemic attack, and revascularization in patients undergoing stress or rest cardiac MRI
Time frame: Ongoing
examine the rate of major cardiovascular events (MACE) defined as cardiac death, non- fatal myocardial infarction, cerebrovascular / transient ischemic attack, and revascularization in patients undergoing stress or rest cardiac MRI and to relate these events to the extent of ischemia and infarction seen on the MRI exams

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 2021.
Background: PubMed 8005123Baer FM, Voth E, Theissen P, Schicha H, Sechtem U. Gradient-echo magnetic resonance imaging during incremental dobutamine infusion for the localization of coronary artery stenoses. Eur Heart J. 1994 Feb;15(2):218-25. doi: 10.1093/oxfordjournals.eurheartj.a060479.
Background: PubMed 7850935Baer FM, Voth E, Schneider CA, Theissen P, Schicha H, Sechtem U. Comparison of low-dose dobutamine-gradient-echo magnetic resonance imaging and positron emission tomography with [18F]fluorodeoxyglucose in patients with chronic coronary artery disease. A functional and morphological approach to the detection of residual myocardial viability. Circulation. 1995 Feb 15;91(4):1006-15. doi: 10.1161/01.cir.91.4.1006.
Background: PubMed 8090892Baer FM, Voth E, Theissen P, Schneider CA, Schicha H, Sechtem U. Coronary artery disease: findings with GRE MR imaging and Tc-99m-methoxyisobutyl-isonitrile SPECT during simultaneous dobutamine stress. Radiology. 1994 Oct;193(1):203-9. doi: 10.1148/radiology.193.1.8090892.
Derived from this study: PubMed 38778036Fujikura K, Sathya B, Acharya T, Benovoy M, Jacobs M, Sachdev V, Hsu LY, Arai AE. CMR provides comparable measurements of diastolic function as echocardiography. Sci Rep. 2024 May 22;14(1):11658. doi: 10.1038/s41598-024-61992-6.
Derived from this study: PubMed 29514708Ta AD, Hsu LY, Conn HM, Winkler S, Greve AM, Shanbhag SM, Chen MY, Patricia Bandettini W, Arai AE. Fully quantitative pixel-wise analysis of cardiovascular magnetic resonance perfusion improves discrimination of dark rim artifact from perfusion defects associated with epicardial coronary stenosis. J Cardiovasc Magn Reson. 2018 Mar 8;20(1):16. doi: 10.1186/s12968-018-0436-0.
Derived from this study: PubMed 29454767Hsu LY, Jacobs M, Benovoy M, Ta AD, Conn HM, Winkler S, Greve AM, Chen MY, Shanbhag SM, Bandettini WP, Arai AE. Diagnostic Performance of Fully Automated Pixel-Wise Quantitative Myocardial Perfusion Imaging by Cardiovascular Magnetic Resonance. JACC Cardiovasc Imaging. 2018 May;11(5):697-707. doi: 10.1016/j.jcmg.2018.01.005. Epub 2018 Feb 14.
Derived from this study: PubMed 25827180Nielles-Vallespin S, Kellman P, Hsu LY, Arai AE. FLASH proton density imaging for improved surface coil intensity correction in quantitative and semi-quantitative SSFP perfusion cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2015 Feb 17;17(1):16. doi: 10.1186/s12968-015-0120-6.
Derived from this study: PubMed 24122452Chen MY, Bandettini WP, Shanbhag SM, Vasu S, Booker OJ, Leung SW, Wilson JR, Kellman P, Hsu LY, Lederman RJ, Arai AE. Concordance and diagnostic accuracy of vasodilator stress cardiac MRI and 320-detector row coronary CTA. Int J Cardiovasc Imaging. 2014 Jan;30(1):109-19. doi: 10.1007/s10554-013-0300-0. Epub 2013 Oct 12.
NIH Clinical Center Detailed Web PageLink provided by the sponsor.

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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.

Arlene Sirajuddin, M.D. principal investigator

National Heart, Lung, and Blood Institute (NHLBI)

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiomyopathy and Congenital Heart Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 2 sites 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 0 inclusion and 27 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 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

examine the rate of major cardiovascular events (MACE) defined as cardiac death, non- fatal myocardial infarction, cerebrovascular / transient ischemic attack, and revascularization in patients undergoing stress or rest cardiac MRI (time frame: Ongoing). 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 NCT00027170, which also lists 8 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 2021.