Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005329
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2000-05-25
Brief Title:
Protein S and Myocardial Infarction
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To test the hypothesis that low levels of free protein S a natural anticoagulant protein in plasma were associated with an increased incidence of myocardial infarction in middle aged men and women
Detailed Description:
BACKGROUND
Free protein S that portion of plasma protein S which is not in complex with C4b binding protein is a cofactor for the anticoagulant effect of activated protein C Patients presenting with acute myocardial infarction have significantly reduced levels of free protein S If the major hypothesis proved correct patients at high risk of myocardial infarction could be identified and could be targeted for future studies to examine specific intervention therapy
DESIGN NARRATIVE
The blinded and prospective study began in 1992 although the grant was first awarded in 1983 The goal was to determine if low levels of free protein S were associated with an increased incidence of myocardial infarction Plasma samples were obtained yearly from 2224 men aged 50-59 years who were participants in the Second Northwick Park Heart Study sponsored by the British Medical Research Council Epidemiology and Medical Care Unit Clinical endpoints for the study were documented fatal and non-fatal myocardial infarction To prevent potential bias this laboratory was blinded to the clinical endpoints until all samples had been collected and all causes of death in the study population had been adjudicated ln addition to free protein S total protein S and C4b binding protein were measured The study design permitted the assessment of the temporal relationship between the development of low free protein S levels and the occurrence of myocardial infarction and the presence or absence of a biologic gradient dose-response between levels of free protein S and the frequency of infarction These two analyses were important in assessing whether the observed association was causal or whether low protein S occured as a consequence of myocardial infarction Three levels of free protein S had been defined prior to initiating the study to determine if the frequency of myocardial infarction did follow a biologic gradient The measurement of other potential markers of risk by other laboratories such as prothrombin fragment Fl2 and factor X activation peptide permitted a comprehensive evaluation of hemostatic risk factors in myocardial infarction A second study was conducted in women to examine protein S as a risk factor for myocardial infarction
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Free protein S that portion of plasma protein S which is not in complex with C4b binding protein is a cofactor for the anticoagulant effect of activated protein C Patients presenting with acute myocardial infarction have significantly reduced levels of free protein S If the major hypothesis proved correct patients at high risk of myocardial infarction could be identified and could be targeted for future studies to examine specific intervention therapy
DESIGN NARRATIVE
The blinded and prospective study began in 1992 although the grant was first awarded in 1983 The goal was to determine if low levels of free protein S were associated with an increased incidence of myocardial infarction Plasma samples were obtained yearly from 2224 men aged 50-59 years who were participants in the Second Northwick Park Heart Study sponsored by the British Medical Research Council Epidemiology and Medical Care Unit Clinical endpoints for the study were documented fatal and non-fatal myocardial infarction To prevent potential bias this laboratory was blinded to the clinical endpoints until all samples had been collected and all causes of death in the study population had been adjudicated ln addition to free protein S total protein S and C4b binding protein were measured The study design permitted the assessment of the temporal relationship between the development of low free protein S levels and the occurrence of myocardial infarction and the presence or absence of a biologic gradient dose-response between levels of free protein S and the frequency of infarction These two analyses were important in assessing whether the observed association was causal or whether low protein S occured as a consequence of myocardial infarction Three levels of free protein S had been defined prior to initiating the study to determine if the frequency of myocardial infarction did follow a biologic gradient The measurement of other potential markers of risk by other laboratories such as prothrombin fragment Fl2 and factor X activation peptide permitted a comprehensive evaluation of hemostatic risk factors in myocardial infarction A second study was conducted in women to examine protein S as a risk factor for myocardial infarction
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL030443 | NIH | None | httpsreporternihgovquickSearchR01HL030443 |