Hypertrophic CardiomyopathyPRIMARyNCT02994615
Evaluating Microvascular Dysfunction in Symptomatic Patients With HypertroPhic CaRdiomyopathy
An observational study of Hypertrophic Cardiomyopathy, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2017to Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptomatic hypertrophic cardiomyopathy versus controls (patients undergoing coronary angiography and FFR
Who may be able to join
- Age 18-80
- Already have an indication for coronary angiography
- Previous diagnosis of hypertrophic cardiomyopathy (unless control)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- Index of Microvascular Resistance, Microvascular dysfunction
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hypertrophic cardiomyopathy | Not described | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
IMR in patients with hypertrophic cardiomyopathy (HCM) versus controls
Measured: 1 day
Secondary outcomes (3)
Number of ventricular tachycardia
Measured during 48 h recording after 6 months
Measured: 6 months
Chest pain - Canadian Cardiovascular Society (CCS) class
Measured: Up to 6 months
Shortness of breath - NYHA class
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionJun 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahar Lavi, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Shahar Lavi, Principal investigator, London Health Sceinces Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994615
- Sponsor's protocol ID
- 108627
- Acronym
- PRIMARy
- Status last verified
- Sep 2020
- First submitted
- 8 Dec 2016
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Microvascular Dysfunction in Symptomatic Patients With HypertroPhic CaRdiomyopathy: The Index of MicrovAscular Resistance (IMR)
- ClinicalTrials.gov ID
- NCT02994615
- Acronym / sponsor ID
- PRIMARy / 108627
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- Index of Microvascular Resistance, Microvascular dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypertrophic cardiomyopathy | – | – |
| Control | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic hypertrophic cardiomyopathy versus controls (patients undergoing coronary angiography and FFR
Key inclusion criteria (3 listed)
- Age 18-80
- Already have an indication for coronary angiography
- Previous diagnosis of hypertrophic cardiomyopathy (unless control)
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IMR in patients with hypertrophic cardiomyopathy (HCM) versus controls
Time frame: 1 day
3 secondary outcomes
Number of ventricular tachycardia
Time frame: 6 months
Chest pain - Canadian Cardiovascular Society (CCS) class
Time frame: Up to 6 months
Shortness of breath - NYHA class
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shahar Lavi principal investigator
London Health Sceinces Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Cardiomyopathy, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IMR in patients with hypertrophic cardiomyopathy (HCM) versus controls (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2020.