CardiomyopathiesIMPAIREDNCT02705170
IMR Assessment in Patients With New Diagnosis of Left Ventricle Dilatation
An observational study of Cardiomyopathies and Microcirculation, run by University Hospital of Ferrara at 1 site in Italy.
Trial summary
To establish if, in patients with new diagnosis of left ventricular dilatation without documentation at the coronary artery angiography of significant coronary artery lesions, there is a damage of the coronary microcirculation at the IMR (index of microcirculatory resistance) assessment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathies, Microcirculation, Microvessels
- What is being tested?
- index of microvascular resistance
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2016to 30 Apr 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing coronary artery angiography for new diagnosis of left ventricular dilatation (dilatative cardiomyopathy)
Who may be able to join
- new diagnosis of left ventricular dilation (dilatative cardiopathy)
- absence of significant (>40%) coronary artery disease at coronary artery angiography
Who cannot join
- history of ischemic heart disease
- history of significant valvular disease
- contraindication to hyperemic agent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Index of Microcirculatory Resistance (IMR) Assessment in Patients With New Diagnosis of Left Ventricular Dilatation Without Significant Coronary Artery Lesions: IMPAIRED Pilot Trial
To establish if, in patients with new diagnosis of left ventricular dilatation without documentation at the coronary artery angiography of significant coronary artery lesions, there is a damage of the coronary microcirculation at the IMR (index of microcirculatory resistance) assessment
Read the detailed description
The Authors will enroll at the moment of coronary artery angiography patients without history of ischemic heart disease and new diagnosis (at transthoracic echocardiography) of left ventricular dilation.
All patients will undergo coronary artery angiography. To be enrolled, it is necessary to have the absence of significant coronary artery stenosis (angiographic evaluation of the lesion >40%) in all the vessels (main and side branch).
The Authors will proceed to perform the evaluation of the index of microvascular resistance (IMR). The target vessel will be the left anterior descending artery.
An intracoronary pressure/temperature sensor-tipped guidewire will be used. Thermodilution curves will be obtained during maximal hyperemia. The IMR will be calculated from the ratio of the mean distal coronary pressure at maximal hyperemia to the inverse of mean hyperemic transit time.
- Conditions
- Cardiomyopathies, Microcirculation, Microvessels
- Being tested
- index of microvascular resistance
- Keywords
- index of microvascular resistance
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
index of microvascular resistanceProcedure or surgery
Measurement of the index of microvascular resistance in the left anterior descending artery
| Study group | Role | What they receive |
|---|---|---|
| left ventricle dilatation | The subjects of the investigation will be patients with recent diagnosis of unknown left ventricle dilatation. These subjects received coronary artery angiography as exam suggested by guidelines to discriminate the cause of left ventricle dilatation. In subjects without documentation of coronary artery lesions, the Authors will assess the index of microvascular resistance. Receives: Procedure: index of microvascular resistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Index of microcirculatory resistance
Measurement of IMR in the left anterior descending artery of patients with new diagnosis of left ventricular dilatation and no significant stenosis in epicardial coronary arteries
Measured: during coronary artery angiography
Secondary outcomes (1)
cardiac death
occurrence of cardiac death at 1 year
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion2 Nov 2017
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathiesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Campo, University Hospital of Ferrara
- Investigators
- Gianluca Campo, MD, Principal investigator, Azienda Ospedaliera Universitaria di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705170
- Sponsor's protocol ID
- 260480
- Acronym
- IMPAIRED
- Status last verified
- May 2018
- First submitted
- 5 Mar 2016
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Index of Microcirculatory Resistance (IMR) Assessment in Patients With New Diagnosis of Left Ventricular Dilatation Without Significant Coronary Artery Lesions: IMPAIRED Pilot Trial
- ClinicalTrials.gov ID
- NCT02705170
- Acronym / sponsor ID
- IMPAIRED / 260480
- Conditions
- Cardiomyopathies, Microcirculation, Microvessels
- Keywords
- index of microvascular resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- 2 Nov 2017 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 10 Mar 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.
To establish if, in patients with new diagnosis of left ventricular dilatation without documentation at the coronary artery angiography of significant coronary artery lesions, there is a damage of the coronary microcirculation at the IMR (index of microcirculatory resistance) assessment
Detailed description
The Authors will enroll at the moment of coronary artery angiography patients without history of ischemic heart disease and new diagnosis (at transthoracic echocardiography) of left ventricular dilation.
All patients will undergo coronary artery angiography. To be enrolled, it is necessary to have the absence of significant coronary artery stenosis (angiographic evaluation of the lesion >40%) in all the vessels (main and side branch).
The Authors will proceed to perform the evaluation of the index of microvascular resistance (IMR). The target vessel will be the left anterior descending artery.
An intracoronary pressure/temperature sensor-tipped guidewire will be used. Thermodilution curves will be obtained during maximal hyperemia. The IMR will be calculated from the ratio of the mean distal coronary pressure at maximal hyperemia to the inverse of mean hyperemic transit time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| left ventricle dilatation | – | Procedure: index of microvascular resistanceThe subjects of the investigation will be patients with recent diagnosis of unknown left ventricle dilatation. These subjects received coronary artery angiography as exam suggested by guidelines to discriminate the cause of left ventricle dilatation. In subjects without documentation of coronary artery lesions, the Authors will assess the index of microvascular resistance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing coronary artery angiography for new diagnosis of left ventricular dilatation (dilatative cardiomyopathy)
Key inclusion criteria (2 listed)
- new diagnosis of left ventricular dilation (dilatative cardiopathy)
- absence of significant (>40%) coronary artery disease at coronary artery angiography
Key exclusion criteria (3 listed)
- history of ischemic heart disease
- history of significant valvular disease
- contraindication to hyperemic agent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| index of microvascular resistanceMeasurement of the index of microvascular resistance in the left anterior descending artery | Procedure or surgery | left ventricle dilatation |
Primary outcome
Index of microcirculatory resistance
Time frame: during coronary artery angiography
Measurement of IMR in the left anterior descending artery of patients with new diagnosis of left ventricular dilatation and no significant stenosis in epicardial coronary arteries
1 secondary outcome
cardiac death
Time frame: 1-year
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 2 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
Gianluca Campo, MD principal investigator
Azienda Ospedaliera Universitaria di Ferrara
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 Cardiomyopathies and Microcirculation, run by University Hospital of Ferrara at 1 site in Italy.
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 2 inclusion and 3 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 2 May 2018. 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 Italy. 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?
Index of microcirculatory resistance (time frame: during coronary artery angiography). 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 2 May 2018.