Myocardial Flow Reserve in Severe AS Without Obstructive Coronary Artery Disease

October 14, 2015 updated by: Samsung Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Severe AS: asymptomatic
Asymptomatic
Other: Adenosine-stress cardiac magnetic resonance imaging
undergoing adenosine-stress cardiac magnetic resonance imaging
Severe AS: pure angina
Presence of exertional chest pain
Other: Adenosine-stress cardiac magnetic resonance imaging
undergoing adenosine-stress cardiac magnetic resonance imaging
Normal controls
Healthy controls
Other: Adenosine-stress cardiac magnetic resonance imaging
undergoing adenosine-stress cardiac magnetic resonance imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

August 31, 2015

First Submitted That Met QC Criteria

October 14, 2015

First Posted (Estimate)

October 15, 2015

Study Record Updates

Last Update Posted (Estimate)

October 15, 2015

Last Update Submitted That Met QC Criteria

October 14, 2015

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-01-014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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