Myocardial Flow Reserve in Severe AS Without Obstructive Coronary Artery Disease

NCT ID: NCT02575768

Last Updated: 2015-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-04-30

Brief Summary

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Exertional angina is common symptom in patients with severe aortic stenosis (AS) without obstructive coronary artery disease (CAD). Although reduced myocardial flow reserve is one of the proposed explanations for angina, little is known about the pathophysiology.

This study aimed that adenosine-stress cardiac magnetic resonance can be used for the assessment of myocardial perfusion reserve and suggest the pathophysiology of development of angina in patients with severe AS without obstructive CAD.

Detailed Description

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Conditions

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Chest Pain Severe Aortic Stenosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Severe AS: asymptomatic

Asymptomatic

Adenosine-stress cardiac magnetic resonance imaging

Intervention Type OTHER

undergoing adenosine-stress cardiac magnetic resonance imaging

Severe AS: pure angina

Presence of exertional chest pain

Adenosine-stress cardiac magnetic resonance imaging

Intervention Type OTHER

undergoing adenosine-stress cardiac magnetic resonance imaging

Normal controls

Healthy controls

Adenosine-stress cardiac magnetic resonance imaging

Intervention Type OTHER

undergoing adenosine-stress cardiac magnetic resonance imaging

Interventions

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Adenosine-stress cardiac magnetic resonance imaging

undergoing adenosine-stress cardiac magnetic resonance imaging

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. severe AS
2. normal LV ejection fraction (EF ≥ 50%)

Exclusion Criteria

1. age \<18
2. LVEF \< 50% in echocardiography
3. concomitant other valvular disease of moderate or severe severity
4. previous aortic valve replacement
5. symptomatic patients other than chest pain
6. obstructive CAD (\>30% luminal stenosis in at least one coronary artery on coronary angiography)
7. history of myocardial infarction or acute coronary syndrome
8. contraindication to adenosine
9. any absolute contraindication to CMR
10. estimated glomerular filtration rate \<30 mL/min/1.73m2.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Society of Cardiovascular Anesthesiologists; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; Bonow RO, Carabello BA, Kanu C, de Leon AC Jr, Faxon DP, Freed MD, Gaasch WH, Lytle BW, Nishimura RA, O'Gara PT, O'Rourke RA, Otto CM, Shah PM, Shanewise JS, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Hunt SA, Lytle BW, Nishimura R, Page RL, Riegel B. ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (writing committee to revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease): developed in collaboration with the Society of Cardiovascular Anesthesiologists: endorsed by the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons. Circulation. 2006 Aug 1;114(5):e84-231. doi: 10.1161/CIRCULATIONAHA.106.176857. No abstract available.

Reference Type BACKGROUND
PMID: 16880336 (View on PubMed)

Silaruks S, Clark D, Thinkhamrop B, Sia B, Buxton B, Tonkin A. Angina pectoris and coronary artery disease in severe isolated valvular aortic stenosis. Heart Lung Circ. 2001;10(1):14-23. doi: 10.1046/j.1444-2892.2001.00060.x.

Reference Type BACKGROUND
PMID: 16352020 (View on PubMed)

Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jun 10;63(22):e57-185. doi: 10.1016/j.jacc.2014.02.536. Epub 2014 Mar 3. No abstract available.

Reference Type BACKGROUND
PMID: 24603191 (View on PubMed)

Ahn JH, Kim SM, Park SJ, Jeong DS, Woo MA, Jung SH, Lee SC, Park SW, Choe YH, Park PW, Oh JK. Coronary Microvascular Dysfunction as a Mechanism of Angina in Severe AS: Prospective Adenosine-Stress CMR Study. J Am Coll Cardiol. 2016 Mar 29;67(12):1412-1422. doi: 10.1016/j.jacc.2016.01.013.

Reference Type DERIVED
PMID: 27012401 (View on PubMed)

Other Identifiers

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2012-01-014

Identifier Type: -

Identifier Source: org_study_id

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