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Improved Heart MRI Techniques for Heart Disease
N/A
Recruiting
Led By Ahmed M Gharib, M.D.
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects with known or suspected atherosclerotic disease based on clinical findings or documented by angiography (conventional, CTA or MRA), or Doppler ultrasound
Subject age greater than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within one month
Awards & highlights
Study Summary
This trial is testing new techniques to improve the quality of heart MRI, compared with more complex studies like catheterization or angiography, in order to better diagnose heart disease.
Who is the study for?
Adults over 18, with or at risk for heart disease (due to factors like smoking, obesity, diabetes), and healthy volunteers can join. They must be stable enough to visit the clinic and agree to participate. Those with MRI contraindications or severe medical conditions that prevent lying still are excluded.Check my eligibility
What is being tested?
The trial is testing new MRI techniques against other diagnostic tests for heart disease. Participants will undergo physical exams, blood tests, angiography, up to five different MRIs, and possibly a CT scan. No treatment is provided in this study.See study design
What are the potential side effects?
There may not be direct side effects from the imaging techniques themselves; however, discomfort from lying still during scans or reactions to contrast agents used in MRIs or CT scans could occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with or suspected to have atherosclerosis.
Select...
I am older than 18 years.
Select...
I am over 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within one month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within one month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To develop and optimize clinical imaging protocols and techniques for fast high- resolution coronary MRA and wall imaging for the assessment of coronary and other main arteries structural distensibility, and endothelial functional parameters@...
To develop, implement, and optimize new non-invasive methods for characterization of the micro-environment in the thoracic and abdominal area utilizing specialized techniques
To evaluate early MR imagery signs of arterial structural, distensibility, and endothelial functional disorders associated with atherosclerosis in a cohort of patients with known or suspected coronary atherosclerosis
Trial Design
4Treatment groups
Experimental Treatment
Group I: Group 4Experimental Treatment1 Intervention
Group 4 no known risk factors (control subjects)They will undergo a series of multiple small discovery studies in order to look at the multiple different MR methods of visualizing the coronary arteries
Group II: Group 3Experimental Treatment1 Intervention
Group 3 will consist of subjects with a 10-year total CHD risk >20% (high)They will undergo a series of multiple small discovery studies in order to look at the multiple different MR methods of visualizing the coronary arteries
Group III: Group 2Experimental Treatment1 Intervention
Group 2 will consist of subjects with a 10-year total CHD risk 10-20% (intermediate)They will undergo a series of multiple small discovery studies in order to look at the multiple different MR methods of visualizing the coronary arteries
Group IV: Group 1Experimental Treatment1 Intervention
Group 1 will consist of subjects with a 10-year total CHD risk <10% (low)They will undergo a series of multiple small discovery studies in order to look at the multiple different MR methods of visualizing the coronary arteries
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,359 Previous Clinical Trials
4,311,495 Total Patients Enrolled
7 Trials studying Atherosclerosis
19,916 Patients Enrolled for Atherosclerosis
Ahmed M Gharib, M.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 Previous Clinical Trials
216 Total Patients Enrolled
1 Trials studying Atherosclerosis
216 Patients Enrolled for Atherosclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am stable enough to visit the clinic for the study.I've had an allergic reaction to gadolinium contrast despite taking allergy and cortisone meds.My kidney function is reduced.I have been diagnosed with or suspected to have atherosclerosis.I am healthy or have a condition affecting my chest, stomach area, or metabolism.I am at risk for heart disease due to factors like smoking, obesity, high cholesterol, high blood pressure, family history of early heart disease, or diabetes.I need sedation to undergo MRI scans.I cannot use beta blockers due to conditions like asthma, severe COPD, heart issues, low blood pressure, or being pregnant/nursing.I cannot lie still on my back for an MRI due to severe back pain or movement issues.I cannot have certain heart imaging tests within 2 months.I am stable enough to visit the clinic for the study.I may or may not have heart disease and have different heart risk factors.I may or may not have heart disease and have different levels of heart risk factors.I cannot use CTA contrast due to high creatinine, myeloma, recent metformin use, or past allergic reactions.I do not have severe heart issues, very low blood pressure, severe anemia, glaucoma, or allergies to nitroglycerin.Your health condition is not good enough to tolerate an MRI scan, and you have medical issues like unstable angina or difficulty breathing at rest.You have a medical implant or condition that makes it unsafe for you to have an MRI scan. This includes having a pacemaker, cochlear implant, or metal shrapnel in your body.I am older than 18 years.You have risk factors for heart disease such as smoking, obesity, high cholesterol, high blood pressure, or a family history of early heart disease.I am over 18 years old.I am healthy or have a condition affecting my chest, stomach area, or metabolism.I am willing to follow the study's requirements.I am willing to follow the study's requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Group 4
- Group 2: Group 3
- Group 3: Group 2
- Group 4: Group 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Atherosclerosis Patient Testimony for trial: Trial Name: NCT01399385 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals still able to join this research endeavor?
"Clinicaltrials.gov reveals that this medical experiment is currently enrolling participants, having originally been posted on June 7th 2011 and recently updated November 9th 2022."
Answered by AI
What is the scope of participants involved in this research?
"Affirmative. According to information hosted on clinicaltrials.gov, this clinical trial began recruiting participants from July 6th 2011 and is still ongoing as of November 9th 2022. There are currently 4000 individuals being recruited across 2 sites."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
New York
Virginia
What site did they apply to?
National Institutes of Health Clinical Center
National Institutes of Health Clinical Center, 9000 Rockville Pike
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Want to be involved in research.
PatientReceived no prior treatments
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