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Evaluating Microvascular Dysfunction in Symptomatic Patients With HypertroPhic CaRdiomyopathy (PRIMARy)

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ClinicalTrials.gov Identifier: NCT02994615
Recruitment Status : Recruiting
First Posted : December 16, 2016
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Shahar Lavi, Lawson Health Research Institute

Brief 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.

Condition or disease
Hypertrophic Cardiomyopathy

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluating Microvascular Dysfunction in Symptomatic Patients With HypertroPhic CaRdiomyopathy: The Index of MicrovAscular Resistance (IMR)
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020


Group/Cohort
hypertrophic cardiomyopathy
Control



Primary Outcome Measures :
  1. IMR in patients with hypertrophic cardiomyopathy (HCM) versus controls [ Time Frame: 1 day ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with symptomatic hypertrophic cardiomyopathy versus controls (patients undergoing coronary angiography and FFR
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994615


Contacts
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Contact: Cassandra Wagner, BSc 5196858500 ext 35626 cassandra.wagner@lhsc.on.ca

Locations
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Canada
London Health Sciences Centre Recruiting
London, Canada
Contact: Shahar Lavi         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Shahar Lavi London Health Sceinces Centre

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Responsible Party: Shahar Lavi, Director of Cardiovascular Interventional Research, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02994615     History of Changes
Other Study ID Numbers: 108627
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Shahar Lavi, Lawson Health Research Institute:
Index of Microvascular Resistance
Microvascular dysfunction
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases