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Carotid artery stenting (CAS) is one of major treatments in prevention of ischemic stroke. Because of sinus reflex due to stenting and balloon dilatation, persistent post-surgery hypotension is a common perioperative event. Persistent hypotension can lead to perioperative adverse events like ischemic stroke, myocardial infraction, renal failure and death; or more usually, it prolongs length of stay and hospital expenses. Renin-angiotensin-aldosterone inhibitor (RASI) could inhibit the release of catecholamine and may lead to higher rate of persistent hypotension after CAS compared to other hypertensives.Thus, the investigators aim to investigate the effect of pre-operation antihypertensive drugs on persistent hypotension after stenting, and followed burden in carotid artery stenting comorbid with hypertension patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RASI group | Experimental | Administer RASI, with or without other antihypertensives except for CCB, and blood pressure should be controlled within the target range (140/90 mmHg). RASI intaking starts at least 5 days before stenting. |
|
| CCB group | Active Comparator | Administer CCB, with or without other antihypertensives except for RASI, and blood pressure should be controlled within the target range (140/90 mmHg). CCB intaking starts at least 5 days before stenting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| administering RASI (the trade name or universal name will not be stipulated) before stenting | Drug | Pre-operative antihypertensive drugs before stenting will be random assigned (RASI or CCB) at least 5 days before stenting. Patients in RASI group will receive RASI (all kinds of RASI will be permited and the trade name or universal name of drugs will not be limited), with or without other antihypertensives except for CCB (any kind of CCB). Blood pressure of patients should be controlled within the target range (140/90 mmHg); and usage and dosage of antihypertensive drugs will not be stipulated. Grapefruit intaking should be avoid. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of persistent post-surgery hypotension | systolic blood pressure (SBP) < 90 mmHg or requiring vasopressor with lasting > 6 hours, and without evidence hypovolemia and heart failure | the first 24 hours after CAS |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay after surgery | From surgery to dicharge, up to 3 month. | |
| Hospital expenses after surgery, based on payment list in hospital information system | Payment list in hospital information system for all patients will be recorded with permission and the hospital expenses after surgery will be caculated based on those records. |
| Measure | Description | Time Frame |
|---|---|---|
| The total incidence of cardiac and cerebral events (stroke, myocardial infarction, heart failure and angina pectoris) and symptomatic hypotension | From administering antihypertensive drugs to stenting, at least 5 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bo Wu, Dr | Contact | +8618980602142 | dr.bowu@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Bo Wu, Dr | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
Outcomes and grouping of patticipants will be shared to all investigators contributing to this study. Study protocol, statistical analysis plan will also be shared.
from 6 month after the recruitment completed
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| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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RASI group and CCB group
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open label, blinded endpoint
|
| administering CCB (the trade name or universal name will not be stipulated) before stenting | Drug | Pre-operative antihypertensive drugs before stenting will be random assigned (RASI or CCB) at least 5 days before stenting. Patients in CCB group will receive CCB (all kinds of CCB will be permited and the trade name or universal name of drugs will not be limited), with or without other antihypertensives except for RASI (any kind of RASI). Blood pressure of patients should be controlled within the target range (140/90 mmHg); and usage and dosage of antihypertensive drugs will not be stipulated. Grapefruit intaking should be avoid. |
|
| From surgery to dicharge, up to 3 month. |
| Difference of serum catecholamine (adrenalin, norepinephrine and dopamine) before and after surgery (all in unit of nmol/L) | at morning (7 o'clock am) of the day of surgery and the first day after surgery |
| Difference of heart rate variability (HRV) before and after surgery | 24 hours before surgery to at least 24 hours after surgery |
| The incidence of bradycardia after surgery | the first 24 hours after CAS |
| The total incidence of stroke, myocardial infraction, renal failure and embolism of retinal arteries | From surgery to dicharge, up to 3 month. |
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |