Cardiovascular Disease Screening

Myocardial Infarction Clinical Trial

Official title:

Suburban/NHLBI Cardiovascular Disease Screening Protocol

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00483951
• Other study ID #: 070157
• Secondary ID: 07-H-0157
• Status: Terminated
• Start date: January 28, 2008
• Est. completion date: November 3, 2020

Study information

• Verified date: November 2020
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.)

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1325
• Est. completion date: November 3, 2020
• Est. primary completion date: November 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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:

• 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.

Related Conditions & MeSH terms

• Acquired Heart Disease
• Atherosclerosis
• Cardiovascular Diseases
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Infarction
• Ischemia
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland
United States	Suburban Hospital	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Hendel RC, Patel MR, Kramer CM, Poon M, Hendel RC, Carr JC, Gerstad NA, Gillam LD, Hodgson JM, Kim RJ, Kramer CM, Lesser JR, Martin ET, Messer JV, Redberg RF, Rubin GD, Rumsfeld JS, Taylor AJ, Weigold WG, Woodard PK, Brindis RG, Hendel RC, Douglas PS, Peterson ED, Wolk MJ, Allen JM, Patel MR; American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group; American College of Radiology; Society of Cardiovascular Computed Tomography; Society for Cardiovascular Magnetic Resonance; American Society of Nuclear Cardiology; North American Society for Cardiac Imaging; Society for Cardiovascular Angiography and Interventions; Society of Interventional Radiology. ACCF/ACR/SCCT/SCMR/ASNC/NASCI/SCAI/SIR 2006 appropriateness criteria for cardiac computed tomography and cardiac magnetic resonance imaging: a report of the American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group, American College of Radiology, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, American Society of Nuclear Cardiology, North American Society for Cardiac Imaging, Society for Cardiovascular Angiography and Interventions, and Society of Interventional Radiology. J Am Coll Cardiol. 2006 Oct 3;48(7):1475-97. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete characterization of patients for screening purpose onto a research protocol.	Complete characterization of patients for the purpose of deciding whether they are eligible for research protocols run by the Cardiovascular Branch.	Ongoing

External Links

•   NIH Clinical Center Detailed Web Page