Thrombolysis in Myocardial Ischemia Trial II (TIMI II)

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Accession Number
HLB00100101a

Study Type
Clinical Trial

Collection Type
Open BioLINCC Study See bottom of this webpage for request information

Study Period
1983-1990

NHLBI Division
DCVS

Dataset(s) Last Updated
June 4, 2018

Primary Publication URLs
N/A

Consent

Commercial Use Data Restrictions No

Data Restrictions Based On Area Of Research No

Commercial Use Specimen Restrictions No

Non-Genetic Use Specimen Restrictions Based On Area Of Use No

Genetic Use Of Specimens Allowed? Yes

Genetic Use Area Of Research Restrictions No

Specific Consent Restrictions
None.

Objectives

To assess whether intravenous tissue-type plasminogen activator (rt-PA) given in the early hours of acute myocardial infarction should be followed by percutaneous transluminal coronary angioplasty (PTCA).

Background

At the start of the clinical trial, coronary artery disease is the leading cause of death in the United States, accounting for almost 500,000 deaths each year. Studies had confirmed that myocardial infarction is related to an occlusive coronary thrombus in up to 80 percent of patients. First and second-generation thrombolytic agents (including streptokinase and rt-PA) had been successfully used to restore myocardial blood flow where thrombus has occluded an infarct-related coronary artery. However, further clinical investigation were necessary to determine the most suitable thrombolytic agent dose and method of administration, the risk of subsequent reocclusion, restenosis, and/or myocardial infarction, the need for additional therapies, and the likelihood of benefit or hemorrhagic complications.

Participants

Patient entry began in April 1986 and ended in June 1988 with enrollment of 3,534 patients who had presented within 4 hours of the onset of chest pain thought to be caused by myocardial infarction. Enrollment criteria were men and women between the ages of 18 and 75.

Design

Patients were treated with intravenous rt-PA within four hours of the onset of chest pain thought to be caused by myocardial infarction and randomly assigned to an invasive strategy or a conservative strategy. The primary endpoint was survival free of recurrent myocardial infarction at six weeks and one year of follow-up. There were 1,681 patients assigned to the delayed invasive strategy in which catheterization was performed between 18 and 48 hours after rt-PA therapy. If catheterization showed a greater than 60 percent subtotal stenosis of the infarct-related artery that was considered to be technically approachable, angioplasty was attempted.
Angioplasty was performed in 60.5 percent of the 1,500 patients who underwent catheterization in the invasive strategy group. The remaining 39.5 percent or 593 patients did not have angioplasty performed. There were 1,658 patients assigned to a conservative strategy in which cardiac catheterization was reserved for the 587 patients who had spontaneous or exercise-induced myocardial ischemia within 21 days of infarction. A total of 13.5 percent of patients in this arm underwent coronary angioplasty, 7.6 percent underwent bypass surgery, and 1.1 percent underwent both procedures; 77 percent of the patients in the conservative strategy group had no revascularization procedure within 21 days of infarction.

TIMI IIA, a subtrial of 586 patients, investigated whether immediate cardiac catheterization with percutaneous transluminal coronary angioplasty, when appropriate, would confer an advantage over the same procedure performed 18 to 48 hours later. All patients were treated with intravenous rt-PA within four hours of the onset of acute myocardial infarction.

Additional Details

Subjects:

PTCA Study: 391

Beta-Blocker Study: 2948

Age:
 

 

PTCA Study

Beta-Blocker Study

All

N

%

N

%

N

%

Age <= 34

5

1.28

48

1.63

53

1.59

Age 35-39

18

4.60

119

4.04

137

4.10

Age 40-44

42

10.74

232

7.87

274

8.21

Age 45-49

37

9.46

340

11.53

377

11.29

Age 50-54

56

14.32

413

14.01

469

14.05

Age 55-59

71

18.16

525

17.81

596

17.85

Age 60-64

68

17.39

506

17.16

574

17.19

Age 65-69

50

12.79

420

14.25

470

14.08

Age >= 70

44

11.25

345

11.70

389

11.65

 
Sex:

 

PTCA Study

Beta-Blocker Study

All

N

%

N

%

N

%

Male

327

83.63

2415

81.92

2742

82.12

Female

64

16.37

533

18.08

597

17.88

 
Race:

 

PTCA Study

Beta-Blocker Study

All

N

%

N

%

N

%

White

377

96.42

2571

87.21

2948

88.29

non-White

14

3.58

377

12.79

391

11.71

 

Please note that biospecimen availability is subject to review by the NHLBI, BioLINCC, and the NHLBI Biorepository. Certain biospecimens may not be made available for your request. Section 3 of the BioLINCC handbook describes the components of the review process

Visits (Vials):
25 July 2023
 
Serum Total
Pre-Treatment 5,173 5,173
1 Hour Post Infusion 7,027 7,027
5 Hours Post Infusion 7,543 7,543
8 Hours Post Infusion 5,988 5,988
Unknown 61 61
Visits (Subjects):
25 July 2023
 
Serum
Total number of subjects Average volume (ml) per subject
Pre-Treatment 1,368 1.08
1 Hour Post Infusion 1,402 1.51
5 Hours Post Infusion 1,481 1.55
8 Hours Post Infusion 1,344 1.38
Unknown 12 1.69

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Resources Available

Specimens and Study Datasets

Materials Available

Study Documents

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