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OpenTrials
Completed

NCT Number: NCT02575768

Myocardial Flow Reserve in Severe AS Without Obstructive Coronary Artery Disease

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.

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Key information

Conditions

Chest Pain Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Severe Aortic Stenosis Signs and Symptoms Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • severe AS
  • normal LV ejection fraction (EF ≥ 50%)

Exclusion criteria

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

Treatment and study plan

Adenosine-stress cardiac magnetic resonance imaging

Other

undergoing adenosine-stress cardiac magnetic resonance imaging

Primary outcomes

  1. Values of the myocardial perfusion reserve index (MPRI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Reduced Myocardial Flow Reserve in Exertional Angina With Severe Aortic Stenosis and Normal Coronary Arteries: Insight From Prospective Observational Adenosine-stress Cardiac Magnetic Resonance Imaging Study

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 15, 2015
Registry last updated
Oct 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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