No Reflow PhenomenonNORM-PPCINCT04017169
No Reflow Phenomenon Incidence and Predictors
An observational study of No Reflow Phenomenon and STEMI, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Background No reflow phenomenon is described in up to 65% of patients undergoing primary percutaneous coronary intervention for ST elevation myocardial infarction (STEMI). It is known to be associated with worse outcomes but predictors of no reflow are not clearly described. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- No Reflow Phenomenon, STEMI
- How many people
- 176 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Oct 2015to 1 Sep 2017
- 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: The cohort is defined as all patients attending with ST elevation myocardial infarction undergoing primary percutaneous coronary intervention. Cases are those subjects who suffered no reflow phenomenon, with control comparators those that had TIMI III flow and grade III myocardial blush post procedure.
Who may be able to join
- Age ≥ 18 years
- Presenting with ST elevation myocardial infarction
- Appropriate for Primary Percutaneous Coronary Intervention
Who cannot join
- Primary Percutaneous Coronary Intervention not performed eg due to non- flow- limiting coronary artery disease
- Unsuccessful PCI
- Thrombolysis
- Patients who do not survive the procedure to leave the catheterisation laboratory
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Castle Hill Hospital (Hull and east Yorkshire Hospitals NHS Trust)
Cottingham, East Yorkshire, HU16 5JQ
About this study
Official title: NO Reflow Phenomenon and Comparison to the Normal Flow Population Post Primary Percutaneous Coronary Intervention for ST Elevation Myocardial Infarction
Background No reflow phenomenon is described in up to 65% of patients undergoing primary percutaneous coronary intervention for ST elevation myocardial infarction (STEMI). It is known to be associated with worse outcomes but predictors of no reflow are not clearly described.
Objectives A single centre case-control observational study of patients presenting with acute myocardial infarction appropriate for PPCI comparing baseline clinical, biochemical and angiographic characteristics between patients with no reflow phenomenon and those without. Aiming to establish incidence for the UK population.
Read more
Secondary outcomes will be to gain further insight into those presenting with STEMI for PPCI and develop a risk model to guide management and clinical outcomes of patients to 30days.
Methods This study will prospectively recruit all consecutive patients attending a single centre for primary percutaneous coronary intervention for STEMI. Angiographic assessment of the recanalised epicardial vessel will be used to diagnose no reflow (reduced TIMI flow or blush grade). Baseline demographic, angiographic and biochemical characteristics and outcomes at 30days for reflow and no reflow cohorts will be statistically assessed and compared with logistic regression.
- Conditions
- No Reflow Phenomenon, STEMI
- Being tested
- No intervention as observational study
- Medical subject headings
- No-Reflow Phenomenon, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention as observational studyOther
| Study group | Role | What they receive |
|---|---|---|
| No reflow phenomenon | Those that during procedure experience no reflow phenomenon
To define no reflow requires:
• Angiographic evidence of reopening of occluded coronary artery and successful stent placement with no evidence of flow-limiting residual stenosis (<50%), dissection, vessel spasm, or thrombus burden
and
* Angiographic documentation of a TIMI flow grade ≤II, or
* A TIMI flow grade III with a myocardial perfusion grade 0 or I, at least 10 min after the end of PCI procedure. Receives: Other: No intervention as observational study | |
| No NRP | Normal angiographic coronary flow/blush post patent culprit vessel. Receives: Other: No intervention as observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of no reflow phenomenon
Measured: 0-2 days
Secondary outcomes (2)
Predictors of no reflow phenomenon
Statistical analysis of multiple variables to find independent predictors
Measured: 0-3 days
MACE outcomes
- Cardiovascular death
- Death
- Hearth Failure (Killip class III/IV)
- MI
- CVA
- Repeat unplanned angiography
- Repeat unplanned revascularisation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start29 Oct 2015
- Primary completion31 May 2016
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Reflow PhenomenonStudies 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
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jennifer A Rossington, BSc MBChB, Principal investigator, Hull University Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017169
- Sponsor's protocol ID
- NORM PPCI
- Acronym
- NORM-PPCI
- Status last verified
- Jul 2019
- First submitted
- 18 Jun 2019
- Last updated
- 29 Jul 2019
- 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 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NO Reflow Phenomenon and Comparison to the Normal Flow Population Post Primary Percutaneous Coronary Intervention for ST Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT04017169
- Acronym / sponsor ID
- NORM-PPCI / NORM PPCI
- Conditions
- No Reflow Phenomenon, STEMI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Study start
- 29 Oct 2015 (actual)
- Primary completion
- 31 May 2016 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 12 Jul 2019 (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.
Background No reflow phenomenon is described in up to 65% of patients undergoing primary percutaneous coronary intervention for ST elevation myocardial infarction (STEMI). It is known to be associated with worse outcomes but predictors of no reflow are not clearly described.
Objectives A single centre case-control observational study of patients presenting with acute myocardial infarction appropriate for PPCI comparing baseline clinical, biochemical and angiographic characteristics between patients with no reflow phenomenon and those without. Aiming to establish incidence for the UK population.
Secondary outcomes will be to gain further insight into those presenting with STEMI for PPCI and develop a risk model to guide management and clinical outcomes of patients to 30days.
Methods This study will prospectively recruit all consecutive patients attending a single centre for primary percutaneous coronary intervention for STEMI. Angiographic assessment of the recanalised epicardial vessel will be used to diagnose no reflow (reduced TIMI flow or blush grade). Baseline demographic, angiographic and biochemical characteristics and outcomes at 30days for reflow and no reflow cohorts will be statistically assessed and compared with logistic regression.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No reflow phenomenon | – | Other: No intervention as observational studyThose that during procedure experience no reflow phenomenon To define no reflow requires: • Angiographic evidence of reopening of occluded coronary artery and successful stent placement with no evidence of flow-limiting residual stenosis (<50%), dissection, vessel spasm, or thrombus burden and * Angiographic documentation of a TIMI flow grade ≤II, or * A TIMI flow grade III with a myocardial perfusion grade 0 or I, at least 10 min after the end of PCI procedure. |
| No NRP | – | Other: No intervention as observational studyNormal angiographic coronary flow/blush post patent culprit vessel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort is defined as all patients attending with ST elevation myocardial infarction undergoing primary percutaneous coronary intervention. Cases are those subjects who suffered no reflow phenomenon, with control comparators those that had TIMI III flow and grade III myocardial blush post procedure.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Presenting with ST elevation myocardial infarction
- Appropriate for Primary Percutaneous Coronary Intervention
Key exclusion criteria (4 listed)
- Primary Percutaneous Coronary Intervention not performed eg due to non- flow- limiting coronary artery disease
- Unsuccessful PCI
- Thrombolysis
- Patients who do not survive the procedure to leave the catheterisation laboratory
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 |
|---|---|---|
| No intervention as observational study | Other | No NRP, No reflow phenomenon |
Primary outcome
Incidence of no reflow phenomenon
Time frame: 0-2 days
2 secondary outcomes
Predictors of no reflow phenomenon
Time frame: 0-3 days
MACE outcomes
Time frame: 30 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 Jul 2019.
- 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.
Jennifer A Rossington, BSc MBChB principal investigator
Hull University Teaching Hospitals NHS Trust
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 No Reflow Phenomenon and STEMI, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 4 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 Jul 2019. 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 United Kingdom. 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?
Incidence of no reflow phenomenon (time frame: 0-2 days). 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 Jul 2019.