Cardiovascular Disease Screening
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00483951 |
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Recruitment Status :
Terminated
(Per IRB recommendation, a separate protocol will be prepared for retrospective data analysis. The current protocol does not have specific hypotheses.)
First Posted : June 8, 2007
Last Update Posted : July 29, 2021
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This study will evaluate volunteers 18 years of age and older to see if they qualify for one of NHLBI s research studies. Tests include the following:
- General medical evaluation, which may include blood tests, chest x-ray, electrocardiogram (ECG) and echocardiogram (heart ultrasound).
- Other tests as appropriate, such as magnetic resonance imaging (MRI), cardiac computed tomography (CT scan of the heart), nuclear stress test and echocardiography stress test.
- X-ray contrast studies of the heart and blood vessels. (These may be excluded in patients with kidney risk factors.)
| Condition or disease | Intervention/treatment |
|---|---|
| Congenital Heart Disease Atherosclerosis Myocardial Ischemia Myocardial Infarction Acquired Heart Disease | Device: Toshiba Aquilion ONE CT Device: SWiemens MRI scanner |
This is a screening protocol. This protocol allows two functions: 1) the protocol allows physicians in the Suburban/NHLBI Cardiovascular Imaging program to evaluate patients referred to the program with clinically indicated studies and research studies. 2) It is also designed to determine if patients may be suitable candidates for one of our NHLBI research protocols.
Patients greater than or equal to 18 years of age referred for possible cardiovascular disease will be enrolled in the protocol for a period of one year. At one year, patients will either be: 1) transferred to one of our specific research MRI or CT protocols, 2) removed from the screening protocol and made inactive, or 3) re-enrolled on the screening protocol with the patient s consent.
| Study Type : | Observational |
| Actual Enrollment : | 1325 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Suburban/NHLBI Cardiovascular Disease Screening Protocol |
| Actual Study Start Date : | January 28, 2008 |
| Actual Primary Completion Date : | November 3, 2020 |
| Actual Study Completion Date : | November 3, 2020 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Patients with known or suspected cardiovascular disease
Patients referred to protocol with known or suspected cardiovascular disease for further evaluation.
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Device: Toshiba Aquilion ONE CT
The Toshiba Aquilion ONE CT system has the ability to acquire whole organ volume images in a single rotation by utilizing an x-ray detector that is configured as 320 detector rows with a 0.5 mm width, providing a z-axis coverage of 16 cm of anatomy. Device: SWiemens MRI scanner Investigational or research MRI coils may be used in the protocol. The coils are noninvasive devices external to the body. The coils act as antennae to receive small radiofrequency signals out of the body. Coils of the type we use are used daily in clinical MRI practice. |
- Complete characterization of patients for screening purpose onto a research protocol. [ Time Frame: Ongoing ]Complete characterization of patients for the purpose of deciding whether they are eligible for research protocols run by the Cardiovascular Branch.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients > 18 years of age referred for possible cardiovascular disease will be enrolled in the protocol for a period of one year.
At one year, patients will either be: 1) transferred to one of our specific research MRI or CT protocols, 2) removed from the screening protocol and made inactive, or 3) re-enrolled on the screening protocol with the patient's consent.
- ELIGIBILITY CRITERIA:
No one will be excluded from this study based on race, gender, or ethnicity.
A. General Inclusion Criteria:
- Age greater than or equal to 18
- Capable of giving informed consent.
B. General Exclusion Criteria:
- Pregnant women (uncertain patients will have urine or blood testing).
- Decompensated heart failure (unable to lie flat in bed).
Test Specific Exclusion Criteria:
A. CT Exclusion Criteria (excludes contrast enhanced CT scan only):
- Allergy to iodinated contrast agent excludes contrast enhanced CT research studies.
- Multiple myeloma.
- Patients with severe kidney disease (eGFR less than 30 mL/min/1.73 m(2).
B. Beta Antagonist Exclusions (excluded the use of beta blocker only):
- Asthma or severe chronic lung disease/emphysema with regular use of inhaler.
- Decompensated heart failure.
C. MRI Exclusion Criteria (excludes MRI scan only):
- Cardiac pacemaker or implantable defibrillator.
- Cerebral aneurysm clip.
- Neural stimulator (e.g. TENS-Unit).
- Any type of ear implant.
- Metal in eye (e.g. from machining).
- Any implanted device (e.g. insulin pump, drug infusion device).
D. Exclusions from MRI contrast agents:
- Lactating women unless they are willing to discard breast milk for 24 hours.
- Severe kidney disease (less than 30 mL/min/1.73 m(2).
E. Vasodilator Exclusions (excludes some vasodilator stress testing):
- Asthma or chronic obstructive pulmonary disease (emphysema) actively treated with bronchodilators or leukotriene receptor antagonists (albuterol, seravent, atrovent, montelukast singulair, zafirlukast Accolate. These conditions only exclude adenosine and dipyridamole.
- Second degree (Type II) and third degree atrioventricular heart block.
F. Exclusions from Dobutamine stress MRI only:
- Severe problems with heart rhythms.
- Severe high blood pressure.
G. Exclusion criteria for atropine (given during dobutamine stress echocardiography when target heart rate not achievable with dobutamine alone).
- Narrow angle glaucoma.
- Known or suspected severe bladder outlet obstruction due to prostatic hypertrophy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483951
| United States, Maryland | |
| Suburban Hospital | |
| Bethesda, Maryland, United States, 20814 | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | |
| Bethesda, Maryland, United States, 20892 | |
| Principal Investigator: | Andrew E Arai, M.D. | National Heart, Lung, and Blood Institute (NHLBI) |
Publications:
| Responsible Party: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00483951 |
| Other Study ID Numbers: |
070157 07-H-0157 |
| First Posted: | June 8, 2007 Key Record Dates |
| Last Update Posted: | July 29, 2021 |
| Last Verified: | November 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
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Transthoracic echocardiography Ischemia Cardiovascular Disease |
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Cardiovascular Diseases Myocardial Infarction Heart Diseases Atherosclerosis Heart Defects, Congenital Myocardial Ischemia Infarction Ischemia |
Pathologic Processes Necrosis Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases Cardiovascular Abnormalities Congenital Abnormalities |