Cardiovascular Disease Screening - Full Text View

Sponsor:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00483951

Purpose

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
Congenital Heart Disease Atherosclerosis Myocardial Ischemia Myocardial Infarction Acquired Heart Disease

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	Suburban/NHLBI Cardiovascular Disease Screening Protocol

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis Coronary Artery Disease Heart Attack Heart Diseases

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Study Start Date:

June 2007

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 (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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483951

Contacts

Contact: Patient Recruitment and Public Liaison Office	(800) 411-1222	prpl@mail.cc.nih.gov
Contact: TTY	1-866-411-1010

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892
Sub-Investigator: Patient Recruitment and Public Liaison Office (PRPL) For more information at the NIH Clinical Center contact
Suburban Hospital	Recruiting
Bethesda, Maryland, United States, 20814

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

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

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. 2005 Aug 2;46(3):552-7.

ClinicalTrials.gov Identifier:	NCT00483951 History of Changes
Other Study ID Numbers:	070157, 07-H-0157
Study First Received:	June 7, 2007
Last Updated:	January 25, 2012
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Myocardial Infarction
Myocardial Ischemia
Atherosclerosis
Congenital Heart Disease

Valvular Heart Disease
Heart Disease
Cardiovascular Disease
Heart Valve Disease

Additional relevant MeSH terms:

Atherosclerosis
Cardiovascular Diseases
Myocardial Ischemia
Coronary Artery Disease
Heart Diseases
Infarction
Ischemia
Myocardial Infarction
Heart Defects, Congenital

Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Coronary Disease
Pathologic Processes
Necrosis
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on February 09, 2012