← Back to Search

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
Must not have
History of allergic reaction to gadolinium contrast agents despite the use of premeditation with an anti-histaminic and cortisone
eGFR < 60 ml/min/1.73m^2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within one month
Awards & highlights

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 below
Select...
I have been diagnosed with or suspected to have atherosclerosis.
Select...
I am older than 18 years.
Select...
I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I've had an allergic reaction to gadolinium contrast despite taking allergy and cortisone meds.
Select...
My kidney function is reduced.
Select...
I do not have severe heart issues, very low blood pressure, severe anemia, glaucoma, or allergies to nitroglycerin.
Select...
I need sedation to undergo MRI scans.
Select...
I cannot use beta blockers due to conditions like asthma, severe COPD, heart issues, low blood pressure, or being pregnant/nursing.
Select...
I cannot lie still on my back for an MRI due to severe back pain or movement issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within one month
This trial's timeline: 3 weeks for screening, Varies for treatment, and within one month for reporting.

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
2,381 Previous Clinical Trials
4,311,102 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

Group 2 Clinical Trial Eligibility Overview. Trial Name: NCT01399385 — N/A
Atherosclerosis Research Study Groups: Group 2, Group 4, Group 3, Group 1
Atherosclerosis Clinical Trial 2023: Group 2 Highlights & Side Effects. Trial Name: NCT01399385 — N/A
Group 2 2023 Treatment Timeline for Medical Study. Trial Name: NCT01399385 — N/A
Atherosclerosis Patient Testimony for trial: Trial Name: NCT01399385 — N/A
~981 spots leftby Nov 2028