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Trial record 59 of 1316 for:    adenosine
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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

Study Description
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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.


Condition or disease Intervention/treatment
Chest Pain Severe Aortic Stenosis Other: Adenosine-stress cardiac magnetic resonance imaging

Study Design
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Study Type : Observational
Actual Enrollment : 104 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Study Start Date : June 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans
Drug Information available for: Adenosine

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications:
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. Review. Erratum in: Circulation. 2007 Apr 17;115(15):e409. Circulation. 2010 Jun 15;121(23):e443.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02575768    
Other Study ID Numbers: 2012-01-014
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: October 15, 2015
Last Verified: June 2012
Additional relevant MeSH terms:
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Adenosine
Aortic Valve Stenosis
Constriction, Pathologic
Chest Pain
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pain
Neurologic Manifestations
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action