Myocardial Flow Reserve in Severe AS Without Obstructive Coronary Artery Disease

Chest Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02575768
• Other study ID #: 2012-01-014
• Status: Completed
• Phase: N/A
• First received: August 31, 2015
• Last updated: October 14, 2015
• Start date: June 2012
• Est. completion date: April 2015

Study information

• Verified date: June 2012
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Chest Pain
• Severe Aortic Stenosis

Intervention

Other:
• Adenosine-stress cardiac magnetic resonance imaging
undergoing adenosine-stress cardiac magnetic resonance imaging

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Values of the myocardial perfusion reserve index (MPRI)	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	No