The Intra-arterial Vasospasm Trial

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Peng Roc Chen, MD
Study ID
NCT01996436
Phase
PHASE4
Status
Terminated

Conditions

  • Cerebral Vasospasm

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Nicardipine — DRUG
    Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
  • Verapamil — DRUG
    Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
  • Nicardipine + Verapamil + Nitroglycerin — DRUG
    Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm

Study Details

The primary objective of the study is to determine the optimal intra-arterial drug treatment regimen for arterial lumen restoration post cerebral vasospasm following aneurysmal subarachnoid hemorrhage. The secondary objective is to evaluate clinical outcome at 90 days post discharge following optimal intra-arterial drug treatment for cerebral vasospasm. We hypothesize that Intra-arterial (IA) infusion of a combination of multiple vasodilators is more efficacious than single agent treatment cerebral vasospasm therapy. All procedures done as a part of this study are standard hospital care procedures done to treat cerebral vasospasm and all drugs to be used are FDA approved.

Key Dates

Start date
Aug 29, 2016
Status verified
Apr 2025
Primary completion
Apr 29, 2024
Completion
Aug 12, 2024

Study Design

Enrollment
92 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Nicardipine
    Group 1 : Nicardipine 5mg per circulation intra-arterial injection, Pharmacological angioplasty
  • Active Comparator: Verapamil
    Group 3: Verapamil 10mg per circulation intra-arterial injection, Pharmacological angioplasty
  • Active Comparator: Nicardipine + Verapamil + Nitroglycerin
    Group 4 : Nicardipine 5mg + Verapamil 10mg + Nitroglycerin 200mcg in 4cc 5 % dextrose in water , intra-arterial injection, Pharmacological angioplasty

Primary Outcome Measure

Post Infusion Improvement Ratio (PIIR) [ Time Frame: pre pharmacological angioplasty blood vessel diameter - 0 min, post pharmacological angioplasty blood vessel diameter- 10 min after infusion ]

Locations (5)

FacilityCityStateZIPSite coordinators
Yale School of MedicineNew HavenConnecticut06520-
Northwell HealthManhassetNew York11030-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
Geisinger ClinicDanvillePennsylvania17822-
University of Texas Medical School at HoustonHoustonTexas77030-

Find similar trials in New Haven, CT

By research site
Yale School of Medicine· New Haven, CTNorthwell Health· Manhasset, NYWake Forest University Health Sciences· Winston-Salem, NCGeisinger Clinic· Danville, PAUniversity of Texas Medical School at Houston· Houston, TX

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