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OpenTrials
Completed

NCT Number: NCT02994615

Evaluating Microvascular Dysfunction in Symptomatic Patients With HypertroPhic CaRdiomyopathy

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.

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Key information

Conditions

Hypertrophic Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

London Health Sciences Centre

London, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. IMR in patients with hypertrophic cardiomyopathy (HCM) versus controls

    Time frame: 1 day

Secondary outcomes

  1. Number of ventricular tachycardia

    Time frame: 6 months

    Measured during 48 h recording after 6 months

  2. Chest pain - Canadian Cardiovascular Society (CCS) class

    Time frame: Up to 6 months

  3. Shortness of breath - NYHA class

    Time frame: Up to 6 months

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

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

Acronym: PRIMARy

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 16, 2016
Registry last updated
Sep 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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