Evaluating Microvascular Dysfunction in Symptomatic Patients With HypertroPhic CaRdiomyopathy

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02994615

Acronym

PRIMARy

Enrollment

Registered

2016-12-16

Start date

2017-01-31

Completion date

2020-06-30

Last updated

2020-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic Cardiomyopathy

Keywords

Index of Microvascular Resistance, Microvascular dysfunction

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
IMR in patients with hypertrophic cardiomyopathy (HCM) versus controls	1 day

Secondary

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

Countries

Canada

Outcome results