Protocol Number: 07-H-0157

Title:

Suburban/NHLBI Cardiovascular Disease Screening Protocol

Number:

07-H-0157

Summary:

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.)

Sponsoring Institute:

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility 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 (children are excluded because coronary disease is rare in this population).

-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:

-Lacting women unless they are willing to discard breast milk for 24 hours.

-Severe kidney disease (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 (® (Registered Trademark)), zafirlukast Accolate® (Registered Trademark). 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.

Special Instructions:

Currently Not Provided

Keywords:

Myocardial Infarction

Myocardial Ischemia

Atherosclerosis

Congenital Heart Disease

Valvular Heart Disease

Recruitment Keyword(s):

Heart Disease

Cardiovascular Disease

Congenital Heart Disease

Heart Valve Disease

Atherosclerosis

Condition(s):

Congenital Heart Disease

Atherosclerosis

Myocardial Ischemia

Myocardial Infarction

Acquired Heart Disease

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Heart, Lung and Blood Institute

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Escolar E, Weigold G, Fuisz A, Weissman NJ. New imaging techniques for diagnosing coronary artery disease. CMAJ. 2006 Feb 14;174(4):487-95

White CS, Kuo D, Kelemen M, Jain V, Musk A, Zaidi E, Read K, Sliker C, Prasad R. Chest pain evaluation in the emergency department: can MDCT provide a comprehensive evaluation? AJR Am J Roentgenol. 2005 Aug;185(2):533-40

Raff GL, Gallagher MJ, O'Neill WW, Goldstein JA. Diagnostic accuracy of noninvasive coronary angiography using 64-slice spiral computed tomography. J Am Coll Cardiol. 2006 Jul 4;48(1):219; author reply 219. J Am Coll Cardiol. 2005 Aug 2;46(3):552-7

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