Cardiovascular Disease Screening

National Institutes of Health (NIH)

Status

Terminated

Conditions

Myocardial Ischemia

Myocardial Infarction

Congenital Heart Disease

Atherosclerosis

Acquired Heart Disease

Treatments

Device: SWiemens MRI scanner

Device: Toshiba Aquilion ONE CT

Study type

Observational

Funder types

NIH

Identifiers

NCT00483951

07-H-0157

070157

Details and patient eligibility

About

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.)

Full description

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.

Enrollment

1,325 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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: