Myocardial Flow Reserve in Severe AS Without Obstructive Coronary Artery Disease

• ClinicalTrials.gov Identifier: NCT02575768
• Recruitment Status: Completed
• First Posted: October 15, 2015
• Last Update Posted: October 15, 2015
• Sponsor: Samsung Medical Center
• 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 *

• 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.
• Silaruks S, Clark D, Thinkhamrop B, Sia B, Buxton B, Tonkin A. Angina pectoris and coronary artery disease in severe isolated valvular aortic stenosis. Heart Lung Circ. 2001;10(1):14-23.
• Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC guideline 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. J Am Coll Cardiol. 2014 Jun 10;63(22):e57-185. doi: 10.1016/j.jacc.2014.02.536. Epub 2014 Mar 3. Erratum in: J Am Coll Cardiol. 2014 Jun 10;63(22):2489. Dosage error in article text.
• Ahn JH, Kim SM, Park SJ, Jeong DS, Woo MA, Jung SH, Lee SC, Park SW, Choe YH, Park PW, Oh JK. Coronary Microvascular Dysfunction as a Mechanism of Angina in Severe AS: Prospective Adenosine-Stress CMR Study. J Am Coll Cardiol. 2016 Mar 29;67(12):1412-1422. doi: 10.1016/j.jacc.2016.01.013.

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

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