New Heart Imaging Techniques to Evaluate Possible Heart Disease

NCT01399385 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4000

Last updated 2026-05-12

No results posted yet for this study

Summary

Background:

\- Imaging tests, such as magnetic resonance imaging (MRI), can provide information about heart and blood vessels. The tests let doctors can see the amount of blood vessel narrowing and vessel wall thickness. This information may help diagnose and treat heart disease and other conditions that lead to heart attacks. Better MRI methods are needed to improve heart disease diagnosis, especially by avoiding the use of radiation. Researchers are testing new techniques to improve the quality of heart MRI, compared with more complex studies like catheterization or angiography.

Objectives:

\- To compare heart MRI techniques with other tests used to diagnose heart disease.

Eligibility:

\- People at least 18 years of age who either have or may have heart disease, or are healthy volunteers.

Design:

* Participants will be screened with a physical exam, medical history, and blood tests.
* They will have an angiography to study the inside of blood vessels. This test is an x-ray study of the blood vessels. It will be done either separately or as part of a set of tests to diagnose possible heart disease.
* Participants will have at least one and up to five MRI scans. The scans will involve different methods of studying the heart and blood vessels. Participants may also have a computed tomography scan to confirm the findings of an MRI scan.
* No treatment will be provided as part of this protocol.

Conditions

Interventions

DEVICE

MR Imaging Techniques - 1

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

DEVICE

MR Imaging Techniques - 2

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

DEVICE

MR Imaging Techniques - 3

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

DEVICE

MR Imaging Techniques - 4

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

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Ahmed M Gharib, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-06
Primary Completion
2028-11-06
Completion
2030-11-05

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01399385 on ClinicalTrials.gov