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Trial record 59 of 1162 for:    adenosine

Myocardial Flow Reserve in Severe AS Without Obstructive Coronary Artery Disease

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ClinicalTrials.gov Identifier: NCT02575768
Recruitment Status : Completed
First Posted : October 15, 2015
Last Update Posted : October 15, 2015
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

Tracking Information
First Submitted Date August 31, 2015
First Posted Date October 15, 2015
Last Update Posted Date October 15, 2015
Study Start Date June 2012
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 14, 2015)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Myocardial Flow Reserve in Severe AS Without Obstructive Coronary Artery Disease
Official 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
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 Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Subjects who had severe AS and normal LV ejection fraction (EF ≥ 50%) in transthoracic echocardiography were included in the investigators' prospective study. Severe AS was defined as aortic valve area index less than 0.6 cm2/m2 as previously published.
Condition
  • Chest Pain
  • Severe Aortic Stenosis
Intervention Other: Adenosine-stress cardiac magnetic resonance imaging
undergoing adenosine-stress cardiac magnetic resonance imaging
Study Groups/Cohorts
  • Severe AS: asymptomatic
    Asymptomatic
    Intervention: Other: Adenosine-stress cardiac magnetic resonance imaging
  • Severe AS: pure angina
    Presence of exertional chest pain
    Intervention: Other: Adenosine-stress cardiac magnetic resonance imaging
  • Normal controls
    Healthy controls
    Intervention: Other: Adenosine-stress cardiac magnetic resonance imaging
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 14, 2015)
104
Original Actual Enrollment Same as current
Actual Study Completion Date April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02575768
Other Study ID Numbers 2012-01-014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Samsung Medical Center
Study Sponsor Samsung Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Samsung Medical Center
Verification Date June 2012