NCT00712894

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

2.3 years

First QC Date

July 8, 2008

Last Update Submit

September 20, 2012

Conditions

Acute Myocardial InfarctionPercutaneous Coronary Intervention

Keywords

Acute myocardial infarctionPercutaneous coronary interventionNo-reflow phenomenonVasodilator agents

Outcome Measures

Primary Outcomes (1)

  • Vessel flow using TIMI flow grade and TIMI frame count

    post-PCI

Secondary Outcomes (5)

  • 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

  • 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

Study Arms (3)

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.

Drug: Diltiazem

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.

Drug: Verapamil

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.

Drug: Nitroglycerin

Interventions

DiltiazemDRUG

Intracoronary Infusion 400-2000ug

D
VerapamilDRUG

Intracoronary Infusion 200-1000ug

V
NitroglycerinDRUG

Intracoronary Infusion 200-1000ug

N

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of acute myocardial infarction
  • Vessel TIMI flow \< grade Ⅲ post-PCI

You may not qualify if:

  • Heart failure of New York Heart Association (NYHA) class Ⅲ to class Ⅳ
  • Sick sinus syndrome
  • Atrioventricular block (grade Ⅱ and above)
  • SBP ≤ 90mmHg or cardiogenic shock
  • Heart Rate ≤60 bpm
  • Pregnancy
  • Renal or hepatic failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

  • 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.

    PMID: 22980307RESULT

MeSH Terms

Conditions

No-Reflow Phenomenon

Interventions

DiltiazemVerapamilNitroglycerin

Condition Hierarchy (Ancestors)

IschemiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPhenethylaminesEthylaminesAminesOrganic ChemicalsNitro Compounds

Study Officials

  • Junbo Ge, M.D.

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cardiology Department

Study Record Dates

First Submitted

July 8, 2008

First Posted

July 10, 2008

Study Start

December 1, 2006

Primary Completion

April 1, 2009

Study Completion

August 1, 2009

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

CN(1)