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NCT02994615 Clinical Trial

Evaluating Microvascular Dysfunction in Symptomatic Patients With HypertroPhic CaRdiomyopathy

Hypertrophic Cardiomyopathy Clinical Trial

— PRIMARy  

Official title:
Evaluating Microvascular Dysfunction in Symptomatic Patients With HypertroPhic CaRdiomyopathy: The Index of MicrovAscular Resistance (IMR)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02994615
Other study ID # 108627
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2017
Est. completion date June 2020

Study information
Verified date September 2020
Source Lawson Health Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients with hypertrophic cardiomyopathy are being compared to a control group. IMR will be assessed with a pressure wire. Clinical f/u at 3 months and 6 months and a 48 hour holter monitor.

Recruitment information / eligibility
Status Completed
Enrollment 19
Est. completion date June 2020
Est. primary completion date June 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Age 18-80

- Already have an indication for coronary angiography

- Previous diagnosis of hypertrophic cardiomyopathy (unless control)

Exclusion Criteria:

- Fractional flow reserve found to be significant (FFR < 0.8)

- Already have a condition associated with or likely to be associated with an elevated IMR (diabetes, cardiac syndrome X, takotsubo cardiomyopathy, hypertensive cardiomyopathy, severe aortic stenosis, STEMI)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Canada London Health Sciences Centre London

Sponsors (1)
Lead Sponsor Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary IMR in patients with hypertrophic cardiomyopathy (HCM) versus controls 1 day
Secondary Number of ventricular tachycardia Measured during 48 h recording after 6 months 6 months
Secondary Chest pain - Canadian Cardiovascular Society (CCS) class Up to 6 months
Secondary Shortness of breath - NYHA class Up to 6 months
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