Cardiovascular Disease Screening

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1325 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-28

Study Completion Date

2020-11-03

Brief Summary

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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.)

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Detailed Description

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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.

Conditions

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Congenital Heart Disease Atherosclerosis Myocardial Ischemia Myocardial Infarction Acquired Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with known or suspected cardiovascular disease

Patients referred to protocol with known or suspected cardiovascular disease for further evaluation.

Toshiba Aquilion ONE CT

Intervention Type DEVICE

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.

SWiemens MRI scanner

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age greater than or equal to 18
* Capable of giving informed consent.

Exclusion Criteria

* Pregnant women (uncertain patients will have urine or blood testing).
* Decompensated heart failure (unable to lie flat in bed).

* 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.

* 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.

* Narrow angle glaucoma.
* Known or suspected severe bladder outlet obstruction due to prostatic hypertrophy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No