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No Reflow Phenomenon Incidence and Predictors (NORM-PPCI)
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.
| Condition or disease | Intervention/treatment |
|---|---|
| No Reflow Phenomenon STEMI | Other: No intervention as observational study |
| Study Type : | Observational |
| Actual Enrollment : | 176 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | NO Reflow Phenomenon and Comparison to the Normal Flow Population Post Primary Percutaneous Coronary Intervention for ST Elevation Myocardial Infarction |
| Actual Study Start Date : | October 29, 2015 |
| Actual Primary Completion Date : | May 31, 2016 |
| Actual Study Completion Date : | September 1, 2017 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
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
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Other: No intervention as observational study |
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No NRP
Normal angiographic coronary flow/blush post patent culprit vessel.
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Other: No intervention as observational study |
- Incidence of no reflow phenomenon [ Time Frame: 0-2 days ]
- Predictors of no reflow phenomenon [ Time Frame: 0-3 days ]Statistical analysis of multiple variables to find independent predictors
- MACE outcomes [ Time Frame: 30 days ]
- Cardiovascular death
- Death
- Hearth Failure (Killip class III/IV)
- MI
- CVA
- Repeat unplanned angiography
- Repeat unplanned revascularisation
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- Age ≥ 18 years
- Presenting with ST elevation myocardial infarction
- Appropriate for Primary Percutaneous Coronary Intervention
Exclusion Criteria:
- 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
| United Kingdom | |
| Castle Hill Hospital (Hull and east Yorkshire Hospitals NHS Trust) | |
| Cottingham, East Yorkshire, United Kingdom, HU16 5JQ | |
| Principal Investigator: | Jennifer A Rossington, BSc MBChB | Hull University Teaching Hospitals NHS Trust |
| Tracking Information | ||||
|---|---|---|---|---|
| First Submitted Date | June 18, 2019 | |||
| First Posted Date | July 12, 2019 | |||
| Last Update Posted Date | July 29, 2019 | |||
| Actual Study Start Date | October 29, 2015 | |||
| Actual Primary Completion Date | May 31, 2016 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures |
Incidence of no reflow phenomenon [ Time Frame: 0-2 days ] | |||
| Original Primary Outcome Measures | Same as current | |||
| Change History | ||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | |||
| Current Other Pre-specified Outcome Measures | Not Provided | |||
| Original Other Pre-specified Outcome Measures | Not Provided | |||
| Descriptive Information | ||||
| Brief Title | No Reflow Phenomenon Incidence and Predictors | |||
| Official Title | NO Reflow Phenomenon and Comparison to the Normal Flow Population Post Primary Percutaneous Coronary Intervention for ST Elevation Myocardial Infarction | |||
| Brief 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. 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. |
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| Detailed Description | Not Provided | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Probability Sample | |||
| 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. | |||
| Condition |
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| Intervention | Other: No intervention as observational study | |||
| Study Groups/Cohorts |
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| Publications * | Not Provided | |||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment |
176 | |||
| Original Actual Enrollment | Same as current | |||
| Actual Study Completion Date | September 1, 2017 | |||
| Actual Primary Completion Date | May 31, 2016 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | United Kingdom | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT04017169 | |||
| Other Study ID Numbers | NORM PPCI | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement |
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| Responsible Party | Hull University Teaching Hospitals NHS Trust | |||
| Study Sponsor | Hull University Teaching Hospitals NHS Trust | |||
| Collaborators | Not Provided | |||
| Investigators |
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| PRS Account | Hull University Teaching Hospitals NHS Trust | |||
| Verification Date | July 2019 | |||
