NCT02650557

Brief Summary

The investigators aimed to investigate the vessel heterogeneity of Thrombolysis in Myocardial Infarction frame count (TFC) in the three coronary arteries, and its relation to P-wave dispersion, in patients with coronary slow flow and otherwise normal coronary arteries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
998

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

1.7 years

First QC Date

January 3, 2016

Last Update Submit

January 6, 2016

Conditions

Keywords

coronary slow flowP-wave dispersion

Outcome Measures

Primary Outcomes (1)

  • Average thrombolysis in myocardial infarction (TIMI) frame count (TFC) in the three coronary arteries and its relation to P waves parameters on ECG in patients with CSF and otherwise normal coronary arteries

    The first frame was defined as the frame in which concentrated dye occupies the full width of the proximal coronary artery lumen, touching both borders of the lumen, and indicates forward motion down the artery. The final frame counted is that in which the contrast first reaches the distal predefined landmark branch without the necessity for full opacification. The difference between maximum and minimum P wave duration (Pmax and Pmin) was calculated from the 12-lead ECG and defined as PWD.

    24-72 hours

Secondary Outcomes (1)

  • maximum and minimum P wave duration (Pmax and Pmin) and major adverse cardiac events (MACE) in patients with CSF and otherwise normal coronary arteries

    24 hours-30 days

Study Arms (2)

CSF group

consecutive patients with angiographically documented CSF

Procedure: angiography

control group

age- and gender-matched control subjects

Procedure: angiography

Interventions

angiographyPROCEDURE

angiography or arteriography is a medical imaging technique used to visualize the inside, or lumen, of blood vessels and organs of the body, with particular interest in the arteries, veins, and the heart chambers. This is traditionally done by injecting a radio-opaque contrast agent into the blood vessel and imaging using X-ray based techniques such as fluoroscopy.

CSF groupcontrol group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All of the subjects had chest pain and were referred to our catheterization laboratory for coronary angiography. Diagnosis of CSF was based on thrombolysis in myocardial infarction (TIMI) frame count (TFC).

You may qualify if:

  • All of the subjects had chest pain and were referred to our catheterization laboratory for coronary angiography

You may not qualify if:

  • Valvular or congenital heart disease
  • Atrial fibrillation or other arrhythmia that would interfere with ECG analysis
  • Left ventricular hypertrophy
  • Myocardial or pericardial disease
  • Chronic obstructive pulmonary disease, or electrolyte abnormalities.
  • Subjects taking antiarrhythmic, antiischemic, β-blocker, or calcium-channel blocker medications were also excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiaodong Zhaung

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Interventions

Cerebral Angiography

Intervention Hierarchy (Ancestors)

NeuroradiographyNeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisAngiographyRadiographyDiagnostic Techniques, CardiovascularDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Officials

  • zhimin du, MD

    fitst affiliated hospital of SYSU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
department of cardiology, first affiliated hoapital of SYSU

Study Record Dates

First Submitted

January 3, 2016

First Posted

January 8, 2016

Study Start

January 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

January 8, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations