Cardiovascular Disease Screening



Status:Suspended
Conditions:Angina, Cancer, Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases, Oncology
Healthy:No
Age Range:18 - 125
Updated:3/24/2019
Start Date:June 6, 2007

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Suburban/NHLBI Cardiovascular Disease Screening Protocol

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.)

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.

- 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 (for all arms):

- 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.
We found this trial at
2
sites
9000 Rockville Pike
Bethesda, Maryland 20892
Phone: 800-411-1222
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8600 Old Georgetown Road
Bethesda, Maryland 20814
301-896-3100
Suburban Hospital Suburban Hospital is a community-based, not-for-profit hospital serving Montgomery County and the surrounding...
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