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

September 28, 2020 updated by: Shahar Lavi, Lawson Health Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • London, Canada
        • London Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with symptomatic hypertrophic cardiomyopathy versus controls (patients undergoing coronary angiography and FFR

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control
hypertrophic cardiomyopathy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IMR in patients with hypertrophic cardiomyopathy (HCM) versus controls
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of ventricular tachycardia
Time Frame: 6 months
Measured during 48 h recording after 6 months
6 months
Chest pain - Canadian Cardiovascular Society (CCS) class
Time Frame: Up to 6 months
Up to 6 months
Shortness of breath - NYHA class
Time Frame: Up to 6 months
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Investigators

  • Principal Investigator: Shahar Lavi, London Health Sceinces Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

December 8, 2016

First Submitted That Met QC Criteria

December 15, 2016

First Posted (Estimate)

December 16, 2016

Study Record Updates

Last Update Posted (Actual)

September 30, 2020

Last Update Submitted That Met QC Criteria

September 28, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 108627

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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