Endothelial DysfunctionNCT00808535
Cardiac Magnetic Resonance Imaging for Detecting Endothelial Dysfunction
An observational study of Endothelial Dysfunction and Myocardial Perfusion Abnormalities, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The goal of this research study is to demonstrate that Cardiac Perfusion MRI with Vasomotor Stress may serve as a non-invasive and less risky imaging technique for detecting non-obstructive perfusion deficits and/or abnormalities in myocardial blood flow (MBF) in patients with endothelial dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction, Myocardial Perfusion Abnormalities, Cardiac MRI Perfusion With Vasomotor Stress
- What is being tested?
- Cardiac Perfusion MRI w Vasomotor Stress
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Mar 2010
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Diagnosed diabetics (less than 5 years) without documented coronary artery disease recruited from UCLA Ambulatory clinics. Healthy controls from general population.
Who may be able to join
- Age 18 to 50 years
- Should be able to sign an informed consent and HIPAA Agreement
- 30 healthy, non-diabetic individuals
- 30 diabetic individuals without documented coronary artery disease
- Diagnosed diabetics less than 5 years
- HbA1c less than 8.0
Who cannot join
- Children under 18 years and adults above 50 years
- Type 1 DM
- Lactating and Pregnant females
- BMI less than 35
- Contraindication to MRI such as pacemaker, defibrillator implants, etc.
- Allergy to MR (paramagnetic) contrast
Show all 21Show fewer
- History of Angina, MI, or documented Coronary Artery Disease
- Previous history of CHF, CABG, Angioplasty and Stenting
- History of Valvular Heart Disease and Congenital Heart Disease
- History of Peripheral Vascular Disease
- History of Cardiac Arrythmias and anti-coagulation therapy
- History of Cerebro-vascular accidents or TIA
- History of active diabetic retinopathy and nephropathy
- Uncontrolled hypertension (systolic > 170 and diastolic >100 mm Hg
- End Stage Renal Disease and patients on dialysis
- HbA1c of 8.0
- Creatinine greater than 1.7 mg/dl
- History of active gastrointestinal bleeding
- History of IV drug use
- Chronic or current steroid treatment
- Growth hormone treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Radiological Sciences
Los Angeles, California, 91324
Wanda C Marfori, MD, 310-206-2531, wmarfori@mednet.ucla.edu
Stefan Ruehm, MD, 3108250958, sruehm@mednet.ucla.edu
About this study
Official title: A Pilot Study of Cardiac Magnetic Resonance Imaging For Detection of Myocardial Perfusion Abnormalities in Endothelial Dysfunction
The goal of this research study is to demonstrate that Cardiac Perfusion MRI with Vasomotor Stress may serve as a non-invasive and less risky imaging technique for detecting non-obstructive perfusion deficits and/or abnormalities in myocardial blood flow (MBF) in patients with endothelial dysfunction.
This is a controlled study, which will enroll approximately 60 subjects (30 diabetics and 30 non-diabetics to serve as healthy controls), and will include male and non-pregnant females, between the ages 18-50 years.
Read more
All eligible participants will sign an informed consent and will complete a Lifestyle Questionnaire. They will undergo blood work which includes:
- 2-hour Oral Glucose Tolerance Test and Fasting Labs for Glucose, Insulin, C-Peptide, HbA1c, Creatinine, and Lipid Panel.
- Urine Albumin to Creatinine ratio for microalbuminuria.
- Serum inflammatory markers: E-selectin, homocysteine, ADMA, VCAM, IL-6, TNFalpha, hs-CRP and PAI-1.
After blood work, all participants will undergo cardiac MR perfusion imaging procedure with Cold Pressor Test and Adenosine Stress Test.
- Conditions
- Endothelial Dysfunction, Myocardial Perfusion Abnormalities, Cardiac MRI Perfusion With Vasomotor Stress, Diabetes
- Being tested
- Cardiac Perfusion MRI w Vasomotor Stress
- Keywords
- Endothelial dysfunction, Cardiac Perfusion MRI, Vasomotor Stress, Cold Pressor Test, Adenosine Stress
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Perfusion MRI w Vasomotor StressProcedure or surgery
All participants will undergo Cardiac Perfusion MRI with Vasomotor Stress. Vasomotor Stress will include both Cold Pressor Test and Adenosine Stress Test.
| Study group | Role | What they receive |
|---|---|---|
| diabetics | Not described Receives: Procedure: Cardiac Perfusion MRI w Vasomotor Stress | |
| healthy controls | Not described Receives: Procedure: Cardiac Perfusion MRI w Vasomotor Stress |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionFeb 2010 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Bracco Diagnostics, Inc
- Investigators
- Stefan Ruehm, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808535
- Sponsor's protocol ID
- CMRI_Perfusion Study
- Status last verified
- Feb 2009
- First submitted
- 15 Dec 2008
- Last updated
- 9 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Cardiac Magnetic Resonance Imaging For Detection of Myocardial Perfusion Abnormalities in Endothelial Dysfunction
- ClinicalTrials.gov ID
- NCT00808535
- Acronym / sponsor ID
- CMRI_Perfusion Study
- Conditions
- Endothelial Dysfunction, Myocardial Perfusion Abnormalities, Cardiac MRI Perfusion With Vasomotor Stress, Diabetes
- Keywords
- Endothelial dysfunction, Cardiac Perfusion MRI, Vasomotor Stress, Cold Pressor Test, Adenosine Stress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Bracco Diagnostics, Inc
- Study start
- Feb 2009
- Primary completion
- Feb 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 16 Dec 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.
The goal of this research study is to demonstrate that Cardiac Perfusion MRI with Vasomotor Stress may serve as a non-invasive and less risky imaging technique for detecting non-obstructive perfusion deficits and/or abnormalities in myocardial blood flow (MBF) in patients with endothelial dysfunction.
This is a controlled study, which will enroll approximately 60 subjects (30 diabetics and 30 non-diabetics to serve as healthy controls), and will include male and non-pregnant females, between the ages 18-50 years.
All eligible participants will sign an informed consent and will complete a Lifestyle Questionnaire. They will undergo blood work which includes:
- 2-hour Oral Glucose Tolerance Test and Fasting Labs for Glucose, Insulin, C-Peptide, HbA1c, Creatinine, and Lipid Panel.
- Urine Albumin to Creatinine ratio for microalbuminuria.
- Serum inflammatory markers: E-selectin, homocysteine, ADMA, VCAM, IL-6, TNFalpha, hs-CRP and PAI-1.
After blood work, all participants will undergo cardiac MR perfusion imaging procedure with Cold Pressor Test and Adenosine Stress Test.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diabetics | – | Procedure: Cardiac Perfusion MRI w Vasomotor Stress |
| healthy controls | – | Procedure: Cardiac Perfusion MRI w Vasomotor Stress |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Diagnosed diabetics (less than 5 years) without documented coronary artery disease recruited from UCLA Ambulatory clinics. Healthy controls from general population.
Key inclusion criteria (6 listed)
- Age 18 to 50 years
- Should be able to sign an informed consent and HIPAA Agreement
- 30 healthy, non-diabetic individuals
- 30 diabetic individuals without documented coronary artery disease
- Diagnosed diabetics less than 5 years
Key exclusion criteria (21 listed)
- Children under 18 years and adults above 50 years
- Type 1 DM
- Lactating and Pregnant females
- BMI less than 35
- Contraindication to MRI such as pacemaker, defibrillator implants, etc.
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 |
|---|---|---|
| Cardiac Perfusion MRI w Vasomotor StressAll participants will undergo Cardiac Perfusion MRI with Vasomotor Stress. Vasomotor Stress will include both Cold Pressor Test and Adenosine Stress Test. | Procedure or surgery | diabetics, healthy controls |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2009.
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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.
Stefan Ruehm, MD principal investigator
University of California, Los Angeles
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 Endothelial Dysfunction and Myocardial Perfusion Abnormalities, run by University of California, Los Angeles 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 6 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 9 Feb 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 9 Feb 2009.