NCT01399385Toboroz

New Heart Imaging Techniques to Evaluate Possible Heart Disease

Magnetic Resonance of Body, Arterial Wall, and Angiography Imaging for Non- Invasive Assessment of Arterial Distensibility, Endothelial Dysfunction and Atherosclerotic Disease Using 1.5T and High Field (3T) MRI: A Technical Development Study of Cardiac and Body Imaging

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 7.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter): Toboroz
Vizsgálattípus: Beavatkozással járó
Résztvevők száma: 4000 (tervezett)
Első benyújtás: 2011. júl. 20.
Kezdés: 2011. júl. 6.
Elsődleges befejezés: 2028. nov. 6.
Fő szponzor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Betegségek: Elhízás
NCT-szám: NCT01399385

Mit vállalsz

Vizsgálat típusa: Beavatkozással járó
Tervezett résztvevők: 4000
2011. júl. 6. és az elsődleges befejezés (2028. nov. 6.) között
1 helyszín, 1 országban
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Korábbi kezelés

Concomitant use of phosphodiesterase-5 inhibitors (sildenafil-Viagra, tadalifil-Cialis, verdenafil-Levitra)

Más betegség

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 with a condition precluding entry into the scanner (e.g. morbid obesity, claustrophobia, etc.).
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.
History of allergic reaction to gadolinium contrast agents despite the use of premeditation 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
Subjects reporting a history of the following conditions will be excluded:
Inferior myocardial infarction with right ventricular involvement
Cardiac tamponade
History of hypersensitivity to nitroglycerin

Laborértékek

eGFR < 60 ml/min/1.73m\^2
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 pre- medication with an anti-histaminic and cortisone.

Egyéb

Subjects requiring sedation for MRI studies.
Pregnant or lactating women.
Severe aortic stenosis
Hypertrophic cardiomyopathy
Constrictive pericarditis
Severe hypotension (systolic BP <90 mmHg)
Uncorrected hypovolemia
Raised intracranial pressure
Glaucoma
Severe anemia

A regiszterben nem jelölt feltételek

INCLUSION CRITERIA:
- 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.

Életkor a regiszterben: 18 év – 100 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

Helyszín	Város	Ország	Helyszín állapota
National Institutes of Health Clinical Center	Bethesda	Egyesült Államok	Toboroz

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