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The purpose of this study is to evaluate the efficacy of three different vasodilators including diltiazem, verapamil and nitroglycerin for reversal of no-reflow/slow-flow during direct percutaneous coronary intervention for acute myocardial infarction.
No-reflow/slow-flow is a frequent observation during direct PCI for AMI and associated with a poor clinical outcome. The present pharmacological management involves the use of different vasodilators including nitrates, verapamil, adenosine and nicorandil. But no randomized trial has been conducted to assess any of these agents, or to determine the appropriate dosage. This prospective randomized study aimed to confirm favorable effects of diltiazem on no-reflow/slow-flow during direct PCI for AMI compared with verapamil and nitroglycerin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D | Experimental | If no-reflow/slow-flow phenomenon was observed post-PCI, intracoronary infusion of diltiazem via an infusion microcatheter distal to the angioplasty site was performed. |
|
| V | Active Comparator | If no-reflow/slow-flow phenomenon was observed post-PCI, intracoronary infusion of verapamil via an infusion microcatheter distal to the angioplasty site was performed. |
|
| N | Active Comparator | If no-reflow/slow-flow phenomenon was observed post-PCI, intracoronary infusion of nitroglycerin via an infusion microcatheter distal to the angioplasty site was performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diltiazem | Drug | Intracoronary Infusion 400-2000ug |
| |
| Verapamil |
| Measure | Description | Time Frame |
|---|---|---|
| Vessel flow using TIMI flow grade and TIMI frame count | post-PCI |
| Measure | Description | Time Frame |
|---|---|---|
| major adverse cardiovascular events (MACE) | within the first 30 days after PCI | |
| Left ventricular ejection fraction (LVEF) through echocardiography | at 1 and 30 days post-PCI | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Junbo Ge, M.D. | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22980307 | Result | Huang D, Qian J, Ge L, Jin X, Jin H, Ma J, Liu Z, Zhang F, Dong L, Wang X, Yao K, Ge J. REstoration of COronary flow in patients with no-reflow after primary coronary interVEntion of acute myocaRdial infarction (RECOVER). Am Heart J. 2012 Sep;164(3):394-401. doi: 10.1016/j.ahj.2012.06.015. |
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| Drug |
Intracoronary Infusion 200-1000ug |
|
| Nitroglycerin | Drug | Intracoronary Infusion 200-1000ug |
|
| NT-proBNP levels |
| at 1 and 30 days post-PCI |
| incidence of complete ST-segment resolution | 3 hours after PCI |
| peak troponin T level | 24 hours after PCI |
| ID | Term |
|---|---|
| D054318 | No-Reflow Phenomenon |
| ID | Term |
|---|---|
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004110 | Diltiazem |
| D014700 | Verapamil |
| D005996 | Nitroglycerin |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009574 | Nitro Compounds |
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