Myocardial Flow Reserve in Severe AS Without Obstructive Coronary Artery Disease

Completed

• Conditions: Severe Aortic Stenosis; Chest Pain
• Interventions: Other: Adenosine-stress cardiac magnetic resonance imaging

• Registration Number: NCT02575768
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2012-06
• Study Start: 2012-06
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Study First Submitted: 2015-08-31
• Study First Submitted QC: 2015-10-14
• Last Update Submitted: 2015-10-14
• Study First Posted: 2015-10-15
• Last Update Posted: 2015-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Severe AS: asymptomatic	Adenosine-stress cardiac magnetic resonance imaging	Asymptomatic
Normal controls	Adenosine-stress cardiac magnetic resonance imaging	Healthy controls
Severe AS: pure angina	Adenosine-stress cardiac magnetic resonance imaging	Presence of exertional chest pain

Primary Outcome Measures

Name	Time	Method
Values of the myocardial perfusion reserve index (MPRI)	Day 1	Signal intensity-time curves were generated for all segments and the maximum upslope of the LV myocardium divided by the maximum upslope of the LV cavity. MPRI \[upslopestress(corrected)/upsloperest(corrected)\] was calculated dividing the segmental upslope value during adenosine and rest. Whole (average of all myocardial segments) MPRI were calculated.