Acute Heart FailureICE-HFNCT04245605
Invasive Coronary Angiography Early in Ischemic Heart Failure
An observational study of Acute Heart Failure, run by Institute for Clinical Evaluative Sciences at 1 site in Canada.
Trial summary
To compare the outcomes of patients with acute heart failure who undergo early coronary angiography vs. usual care Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- Coronary angiography
- Type of treatment
- Surgery or procedure
- How many people
- 2,994 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2010to 30 Sep 2021
- 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: Hospitalized patients in Ontario, Canada with acute heart failure
Who may be able to join
None listed.
Who cannot join
- Recent myocardial infarction
- Coronary angiogram or revascularization within previous 3 months before admission
- Nonresidents of Ontario, invalid health card number
- HF diagnosed after admission
- Admission BNP or NT-proBNP not diagnostic of HF
- Died within 14 days of admission
Show all 14Show fewer
- Palliative within 6 months prior to hospital admission
- Elevated creatinine concentration
- Documented anaphylactic contrast allergy
- Ischemic or hemorrhagic stroke within 3 months prior to admission
- Highest category of Hospital Frailty Risk Score
- Active severe bleeding at time of hospital admission
- Absolute platelet count < 20
- Metastatic cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Invasive Coronary Angiography Early in Ischemic Heart Failure (ICE-HF)
To compare the outcomes of patients with acute heart failure who undergo early coronary angiography vs. usual care
- Conditions
- Acute Heart Failure
- Being tested
- Coronary angiography
- Keywords
- Coronary angiography, Invasive strategy, Myocardial infarction, Troponin, Heart failure
- Medical subject headings
- Myocardial Infarction, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary angiographyProcedure or surgery
Also called Diagnostic coronary angiography
Coronary angiogram performed either in hospital or post-discharge, within 14 days after initial hospital presentation with heart failure
| Study group | Role | What they receive |
|---|---|---|
| Early angiography | Patients admitted to hospital with acute heart failure undergoing coronary angiography within 14 days of hospital admission Receives: Procedure: Coronary angiography | |
| Control | Patients admitted to hospital with acute heart failure not undergoing coronary angiography within 14 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Death from any cause after 14 days in landmark analysis
Measured: 2 years
Cardiovascular mortality
Death due to cardiovascular causes after 14 days in landmark analysis
Measured: 2 years
Secondary outcomes (4)
All-cause hospital readmission
Readmissions for all causes after 14 days or hospital discharge in landmark analysis
Measured: 2 years
Heart failure readmission
Readmissions for heart failure after 14 days or hospital discharge in landmark analysis
Measured: 2 years
Readmission for myocardial infarction
Readmissions for myocardial infarction after 14 days or hospital discharge in landmark analysis
Measured: 2 years
Rates of revascularization
Coronary revascularization with CABG surgery or PCI procedure
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start1 Apr 2010
- Primary completion31 Mar 2015
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies 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
- Retrospective
- Enrolment
- 2,994 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical Evaluative Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas Lee, Institute for Clinical Evaluative Sciences
- Investigators
- Douglas Lee, MD, PhD, Principal investigator, ICES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245605
- Sponsor's protocol ID
- 3
- Acronym
- ICE-HF
- Status last verified
- Aug 2022
- First submitted
- 27 Jan 2020
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invasive Coronary Angiography Early in Ischemic Heart Failure (ICE-HF)
- ClinicalTrials.gov ID
- NCT04245605
- Acronym / sponsor ID
- ICE-HF / 3
- Conditions
- Acute Heart Failure
- Keywords
- Coronary angiography, Invasive strategy, Myocardial infarction, Troponin, Heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,994 participants (actual)
- Lead sponsor
- Institute for Clinical Evaluative SciencesUniversity, hospital or other
- Study start
- 1 Apr 2010 (actual)
- Primary completion
- 31 Mar 2015 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 29 Jan 2020 (actual)
- 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 compare the outcomes of patients with acute heart failure who undergo early coronary angiography vs. usual care
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early angiography | – | Procedure: Coronary angiographyPatients admitted to hospital with acute heart failure undergoing coronary angiography within 14 days of hospital admission |
| Control | – | –Patients admitted to hospital with acute heart failure not undergoing coronary angiography within 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients in Ontario, Canada with acute heart failure
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- Recent myocardial infarction
- Coronary angiogram or revascularization within previous 3 months before admission
- Nonresidents of Ontario, invalid health card number
- HF diagnosed after admission
- Admission BNP or NT-proBNP not diagnostic of HF
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 |
|---|---|---|
| Coronary angiographyAlso: Diagnostic coronary angiographyCoronary angiogram performed either in hospital or post-discharge, within 14 days after initial hospital presentation with heart failure | Procedure or surgery | Early angiography |
Primary outcome
All-cause mortality
Time frame: 2 years
Death from any cause after 14 days in landmark analysis
Cardiovascular mortality
Time frame: 2 years
Death due to cardiovascular causes after 14 days in landmark analysis
4 secondary outcomes
All-cause hospital readmission
Time frame: 2 years
Heart failure readmission
Time frame: 2 years
Readmission for myocardial infarction
Time frame: 2 years
Rates of revascularization
Time frame: 90 days
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 29 Aug 2022.
- 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.
Douglas Lee, MD, PhD principal investigator
ICES
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 Acute Heart Failure, run by Institute for Clinical Evaluative Sciences 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 0 inclusion and 14 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 29 Aug 2022. 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?
All-cause mortality (time frame: 2 years). The study lists 2 primary outcomes in all. 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 29 Aug 2022.