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Trial Outcomes & Findings for The Clinical Diagnosis Meaning of MIF in Coronary Heart Disease (NCT NCT01750502)

NCT ID: NCT01750502

Last Updated: 2015-03-04

Results Overview

Participants will be extracted 3ml blood before surgery 5 minutes,detection MIF concentration on two groups.We hypothesis that the experimental group will be higher than control group.

Recruitment status

COMPLETED

Target enrollment

256 participants

Primary outcome timeframe

Before surgery 5 minutes

Results posted on

2015-03-04

Participant Flow

Sequencing was carried out after polymerase chain reaction with DNA specimens from 186 volunteers without CHD and 70 patients with CHD. CHD was confirmed by Coronary Angiography (CAG).

Participant milestones

Participant milestones
Measure
Coronary-artery-disease Group
Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
Non-coronary-artery-disease Group
Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
Overall Study
STARTED
70
186
Overall Study
COMPLETED
70
186
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Clinical Diagnosis Meaning of MIF in Coronary Heart Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Coronary-artery-disease Group
n=70 Participants
Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
Non-coronary-artery-disease Group
n=186 Participants
Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
Total
n=256 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
59 Participants
n=5 Participants
151 Participants
n=7 Participants
210 Participants
n=5 Participants
Age, Categorical
>=65 years
11 Participants
n=5 Participants
35 Participants
n=7 Participants
46 Participants
n=5 Participants
Age, Continuous
64.02 years
STANDARD_DEVIATION 8.57 • n=5 Participants
65.9 years
STANDARD_DEVIATION 10.03 • n=7 Participants
64.96 years
STANDARD_DEVIATION 9.07 • n=5 Participants
Sex: Female, Male
Female
33 Participants
n=5 Participants
97 Participants
n=7 Participants
130 Participants
n=5 Participants
Sex: Female, Male
Male
37 Participants
n=5 Participants
89 Participants
n=7 Participants
126 Participants
n=5 Participants
Region of Enrollment
China
70 participants
n=5 Participants
186 participants
n=7 Participants
256 participants
n=5 Participants
Hypertension
Hypertension
46 participants
n=5 Participants
111 participants
n=7 Participants
157 participants
n=5 Participants
Hypertension
Not Hypertension
24 participants
n=5 Participants
75 participants
n=7 Participants
99 participants
n=5 Participants
HDL-C
1.01 mmol/L
STANDARD_DEVIATION 0.23 • n=5 Participants
0.98 mmol/L
STANDARD_DEVIATION 0.22 • n=7 Participants
0.99 mmol/L
STANDARD_DEVIATION 0.22 • n=5 Participants
LDL-C
2.47 mmol/L
STANDARD_DEVIATION 0.74 • n=5 Participants
2.4 mmol/L
STANDARD_DEVIATION 1.43 • n=7 Participants
2.44 mmol/L
STANDARD_DEVIATION 0.98 • n=5 Participants

PRIMARY outcome

Timeframe: Before surgery 5 minutes

Population: All participants drawn from hospital inpatient cardiovascular medicine between June 2012-January 2013.This analysis was per protocol, but not intention to treat.Because the number of CHD group is less than the normal group during hospitalization.

Participants will be extracted 3ml blood before surgery 5 minutes,detection MIF concentration on two groups.We hypothesis that the experimental group will be higher than control group.

Outcome measures

Outcome measures
Measure
Non-coronary-artery-disease Group
n=186 Participants
Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
Coronary-artery-disease Group
n=70 Participants
Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
5 Minutes After the Opening of the Balloon
Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
Comparison Between Coronary-artery-disease Group and Non-coronary-artery-disease Group on MIF Concentration
48.08 MIF Concentration,ug/L
Standard Deviation 6.48
66.79 MIF Concentration,ug/L
Standard Deviation 6.29
—

SECONDARY outcome

Timeframe: 3 times including before surgery 5 minutes, 5 minutes after the opening of the balloon and after surgery 5 minutes

Population: Coronary-artery-disease Group does not include myocardial infarction, 21 patients were acute myocardial infarction participants.

Percutaneous Coronary Intervention are extracted 3 times including before surgery 5 minutes , 5 minutes after the opening of the balloon and after surgery 5 minutes ,and detection MIF concentration .

Outcome measures

Outcome measures
Measure
Non-coronary-artery-disease Group
n=21 Participants
Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
Coronary-artery-disease Group
n=21 Participants
Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
5 Minutes After the Opening of the Balloon
n=21 Participants
Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
Comparison the Change of MIF Before and After Percutaneous Coronary Intervention （PCI） at the Patients Who Are Acute Coronary Syndromes and Stable Ischemic Heart Disease
85.51 MIF Concentration , ug/L
Standard Deviation 6.44
85.40 MIF Concentration , ug/L
Standard Deviation 7.18
84.7 MIF Concentration , ug/L
Standard Deviation 5.21

OTHER_PRE_SPECIFIED outcome

Timeframe: Before surgery

Outcome measures

Outcome measures
Measure
Non-coronary-artery-disease Group
n=70 Participants
Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
Coronary-artery-disease Group
n=186 Participants
Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
5 Minutes After the Opening of the Balloon
Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
Comparison With MIF-173G/C Genotypes of CHD Patients and Controls.
Genotypes of CC
10 participants
6 participants
—
Comparison With MIF-173G/C Genotypes of CHD Patients and Controls.
Genotypes of CG
14 participants
44 participants
—
Comparison With MIF-173G/C Genotypes of CHD Patients and Controls.
Genotypes of GG
46 participants
136 participants
—

OTHER_PRE_SPECIFIED outcome

Timeframe: Before surgery

Population: All participants drawn from hospital inpatient cardiovascular medicine between June 2012-January 2013.This analysis was per protocol, but not intention to treat.Because the number of CHD group is less than the normal group during hospitalization.

Outcome measures

Outcome measures
Measure
Non-coronary-artery-disease Group
n=186 Participants
Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
Coronary-artery-disease Group
n=70 Participants
Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
5 Minutes After the Opening of the Balloon
Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
Comparison of MIF-173G/C Alleles of CHD Patients and Controls.
alleles of G
316 alleles
106 alleles
—
Comparison of MIF-173G/C Alleles of CHD Patients and Controls.
alleles of C
56 alleles
34 alleles
—

Adverse Events

Coronary-artery-disease Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Non-coronary-artery-disease Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. JiFei Tang

Department of Cardiology, the Second Affiliated Hospital, Wenzhou Medical University, Zhejiang province, Wenzhou,China

Phone: 15968766021

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60