New Heart Imaging Techniques to Evaluate Possible Heart Disease

  • STATUS
    Recruiting
  • End date
    Nov 5, 2030
  • participants needed
    4000
  • sponsor
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Updated on 3 February 2021
atherosclerosis
diabetes
angiography
cardiovascular disease
ct scan
hypertension
metabolic syndrome
diabetes mellitus
heart disease
blood test
fats
hyperlipidemia

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.

Description

Specialized imaging techniques now available allow a unique opportunity to characterize the micro-environment of the human body. Magnetic Resonance (MR) vascular wall imaging and angiography (MRA) are developing techniques that permit non-invasive evaluation of arterial and venous structures without the need for x-ray based catheter angiography. In addition, vessel wall imaging provides unprecedented non-invasive tools to assess vascular endothelial function. While dramatic progress has been made to cardiovascular MR imaging in the last few years, there are still substantial limitations in the resolution, accuracy, and reproducibility of MRA and wall imaging in the comprehensive structural and functional evaluation of coronary artery. The first aim of this study is 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. Technique optimization and performance evaluation will be accomplished in normal subjects without known or suspected coronary atherosclerosis. The second aim of this protocol is 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. Results from accelerated high-resolution MRA will be correlated with corresponding Computerized Tomography Coronary Angiogram (CTA) results. The third aim of this protocol is to develop, implement, and optimize new non-invasive methods for characterization of the micro-environment in the thoracic and abdominal area utilizing specialized techniques such as MR Spectroscopy, MR Elastography, and blood oxygenation level dependent (BOLD) imaging. The long-term objective of this study and research initiative is to optimize coronary MRA, wall, and body imaging techniques to the point that it can reliably be used for routine prevention and assessment of early atherosclerosis and other diseases.

Details
Condition NIDDM, Diabetes Mellitus, adiposity, Obesity, Arterial Occlusive Disease, Atherosclerosis, Arteriosclerosis, Diabetes Mellitus, Type 2, Diet and Nutrition, healthy, Chronic Diarrhea, Skin Wounds, Chronic Shoulder Pain, Diabetes Prevention, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Diabetes Mellitus Types I and II, Near-Sighted Corrective Surgery, Healthy Volunteers, Peripheral Arterial Occlusive Disease, Brain Function, Recurrent Respiratory Papillomatosis, Razor Bumps (Pseudofolliculitis Barbae), Diabetes (Pediatric), Occlusions, Metastatic Triple-Negative Breast Cancer, Diabetes Mellitus Type 2, Diabetes, type 2 diabetes mellitus, diabetes mellitus (dm), type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment MR Imagining Techniques
Clinical Study IdentifierNCT01399385
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last Modified on3 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Do you have any of these conditions: or Diabetes Mellitus Type 2 or Arterial Occlusive Disease or healthy or Diet and Nutrition or Obesity or Diabetes Mellitus Types I and II or Skin Wou...?
Do you have any of these conditions: Primary Immunodeficiency or Recurrent Respiratory Papillomatosis or Diet and Nutrition or diabetes type 2 or Diabetes (Pediatric) or healthy or type i...?
Do you have any of these conditions: type ii diabetes or Arteriosclerosis or Healthy Volunteers or Diabetes Mellitus Type 2 or Skin Wounds or Pediatric Health or Diabetes Mellitus or Chro...?
Do you have any of these conditions: or Arterial Occlusive Disease or Razor Bumps (Pseudofolliculitis Barbae) or Vaginal Atrophy or Skin Wounds or Diabetes Mellitus, Type 2 or Breast Can...?
Do you have any of these conditions: or Healthy Volunteers or type 2 diabetes or Arterial Occlusive Disease or Pediatric Health or adiposity or Diabetes Mellitus, Type 2 or Injection Por...?
Do you have any of these conditions: adiposity or or Metastatic Triple-Negative Breast Cancer or Adverse Effects, Drugs or Arteriosclerosis or diabetes mellitus (dm) or Diabetes Preventi...?
Do you have any of these conditions: or Arterial Occlusive Disease or Primary Immunodeficiency or type 2 diabetes mellitus or diabetes mellitus (dm) or Chronic Shoulder Pain or Chronic D...?
Do you have any of these conditions: Atherosclerosis or or Diabetes or Chronic Diarrhea or Skin Wounds or Injection Port or Primary Immunodeficiency or Adverse Effects, Drugs or Pediatri...?
Do you have any of these conditions: or Healthy Volunteers or healthy or Diabetes Mellitus Types I and II or Breast Cancer - HER2 Positive or Chronic Shoulder Pain or Vaginal Atrophy or ...?
Is your age greater than or equal to 18 yrs?
Do you have any of these conditions: or Pediatric Health or Atherosclerosis or type ii diabetes or Diabetes Mellitus, Type 2 or adiposity or Metastatic Triple-Negative Breast Cancer or n...?
Do you have any of these conditions: or adiposity or healthy or type ii diabetes or Diabetes or Near-Sighted Corrective Surgery or Diabetes (Pediatric) or diabetes mellitus (dm) or type ...?
Do you have any of these conditions: or Near-Sighted Corrective Surgery or Diabetes Mellitus Type 2 or Razor Bumps (Pseudofolliculitis Barbae) or Primary Immunodeficiency or Occlusions o...?
Do you have any of these conditions: or diabetes type 2 or Chronic Diarrhea or adiposity or Peripheral Arterial Occlusive Disease or Chronic Shoulder Pain or Skin Wounds or Occlusions or...?
Do you have any of these conditions: Diabetes Mellitus, Type 2 or or Brain Function or Diabetes Mellitus Type 2 or healthy or Pediatric Health or adiposity or Chronic Diarrhea or Recurre...?
Do you have any of these conditions: or Healthy Volunteers or healthy or Diabetes Mellitus Types I and II or Recurrent Respiratory Papillomatosis or Injection Port or NIDDM or Metastatic...?
Gender: Male or Female
Subjects with or without history of cardiovascular diseases and with various degrees of cardiovascular risk factor. Subjects with known or suspected atherosclerotic disease based on clinical findings or documented by angiography (conventional, CTA or MRA), or Doppler ultrasound. And, healthy volunteers and subjects with known or suspected diseases affecting the thoracic organs, abdominal organs, and other organs affected by metabolic diseases such as body fat and muscles. Subjects at risk for atherosclerosis including: smoking, obesity, hyperlipidemia, low levels of high density lipoproteins (<50 mg/dl for women and <40 mg/dl for men), hypertension, family history (early onset atherosclerosis <55 year old in male and < 65 year old in female who is first degree relative), and diabetes mellitus or metabolic syndrome
Subject must be willing to participate in the protocol
Subject age greater than 18 years old
Subject must be able to provide informed consent
Subject must be clinically stable and be able to come to the Clinical Center to participate in the study

Exclusion Criteria

Subjects with contraindication to MRI scanning. These contraindications include but are not limited to the following devices or conditions
Implanted cardiac pacemaker or defibrillator
Cochlear Implants
Ocular foreign body (e.g. metal shavings)
Embedded shrapnel fragments
Central nervous system aneurysm clips
Implanted neural stimulator
Medical infusion pumps
Any implanted device that is incompatible with MRI
Unsatisfactory performance status as judged by the referring physician such that the subject could not tolerate an MRI scan. Examples of medical conditions that would not be accepted would include unstable angina and dyspnea at rest
Subjects requiring sedation for MRI studies
Subjects with a condition precluding entry into the scanner (e.g. morbid obesity, claustrophobia, etc.)
Pregnant or lactating women
Subjects with severe back-pain or motion disorders who will be unable to tolerate supine positioning within the MRI scanner and hold still for the duration of the examination
Subjects who are unable to undergo a CTA within 2 months of the MRA part of this study, or are unable to undergo or be scheduled for a cardiac catheterization within 2 months of the MRA
EXCLUSION CRITERIA - FOR GADOLINIUM BASED MRI STUDIES ONLY
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
EXCLUSION CRITERIA - FOR CORONARY CTA
Contraindication to the use of CTA contrast agents
Creatinine value > 1.4 mg/dl
History of multiple myeloma
Use of metformin-containing products less than 24 hrs prior to contrast administration
History of allergic reaction to CTA contrast agents despite the use of premedication with an anti-histaminic and cortisone
Subjects with contraindication precluding the use of beta blockers necessary to perform the coronary CTA. These include
Asthma
Active bronchospasm
Moderate or severe COPD
2nd or 3rd degree AV block
Decompensated cardiac failure
Allergy to beta blockers
Systolic blood pressure < 100 mm Hg
Pregnancy or nursing
EXCLUSION CRITERIA - FOR NITROGLYCERIN USE
Subjects reporting a history of the following conditions will be excluded
Severe aortic stenosis
Hypertrophic cardiomyopathy
Inferior myocardial infarction with right ventricular involvement
Cardiac tamponade
Constrictive pericarditis
Severe hypotension (systolic BP <90 mmHg)
Uncorrected hypovolemia
Raised intracranial pressure
Glaucoma
Severe anemia
Concomitant use of phosphodiesterase-5 inhibitors (sildenafil-Viagra, tadalifil-Cialis, verdenafil-Levitra)
History of hypersensitivity to nitroglycerin
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