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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

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

No Placebo-Only Group

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.

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.

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

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I have been diagnosed with or suspected to have atherosclerosis.

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I am older than 18 years.

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I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I've had an allergic reaction to gadolinium contrast despite taking allergy and cortisone meds.

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My kidney function is reduced.

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I do not have severe heart issues, very low blood pressure, severe anemia, glaucoma, or allergies to nitroglycerin.

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I need sedation to undergo MRI scans.

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I cannot use beta blockers due to conditions like asthma, severe COPD, heart issues, low blood pressure, or being pregnant/nursing.

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I cannot lie still on my back for an MRI due to severe back pain or movement issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within one month

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 9Eligibility criteria met